The 47 references with contexts in paper D. Goryachev V., M. Telnykh Yu., N. Bunyatyan D., Д. Горячев В., М. Тельных Ю., Н. Бунятян Д. (2018) “Регуляторные подходы к оценке биоаналогов для лечения ревматических заболеваний // Regulatory approaches to evaluation of biosimilars for treatment of rheumatic diseases” / spz:neicon:vedomostincesmp:y:2017:i:3:p:155-163

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The Federal Law of the Russian Federation of 12.04.2010 ¹ 61-FZ «On Circulation of Medicines». Available from: https://goo.gl/ JgCdAv (in Russian).
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    Áèîàíàëîãîâûé (áèîïîäîáíûé) ëåêàðñòâåííûé ïðåïàðàò (áèîàíàëîã) — áèîëîãè÷åñêèé ëåêàðñòâåííûé ïðåïàðàò (ËÏ), ñõîæèé ïî ïàðàìåòðàì êà÷åñòâà, ýôôåêòèâíîñòè è áåçîïàñíîñòè ñ ðåôåðåíòíûì áèîëîãè÷åñêèì ËÏ â òàêîé æå ëåêàðñòâåííîé ôîðìå è èìåþùèé èäåíòè÷íûé ñïîñîá ââåäåíèÿ
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    . Ðåôåðåíòíûå ïðåïàðàòû ìîíîêëîíàëüíûõ àíòèòåë â êîíöå ÕÕ âåêà êàðäèíàëüíî èçìåíèëè âçãëÿä ðåâìàòîëîãîâ íà ëå÷åíèå ðåâìàòîèäíîãî àðòðèòà — îäíîãî èç íàèáîëåå ÷àñòûõ âîñïàëèòåëüíûõ çàáîëåâàíèé ñóñòàâî⠗ è ðÿäà èíûõ ðåâìàòè÷åñêèõ çàáîëåâàíèé.

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Stateregisterofmedicines[Internet].Availablefrom: https://grls.rosminzdrav.ru (in Russian).
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     2009 ãîäó ÂÎÇ ïóáëèêóåò ðóêîâîäñòâî ïî îöåíêå áèîàíàëîãè÷íîñòè ïðåïàðàòîâ [7], òðåáîâàíèÿ êîòîðîãî ñòàëè îñíîâîé ïðè ðàçðàáîòêå ïîäõîäîâ áèîàíàëîãè÷íîñòè â Êîðåå è ñòðàíàõ Ëàòèíñêîé Àìåðèêè [8]. Òàáëèöà 1 ÁÈÎËÎÃÈ×ÅÑÊÈÅ ÏÐÅÏÀÐÀÒÛ ÄËß ËÅ×ÅÍÈß ÐÅÂÌÀÒÈ×ÅÑÊÈÕ ÇÀÁÎËÅÂÀÍÈÉ
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    Ïðåïàðàò (ÌÍÍ)Ìåõàíèçì äåéñòâèÿÏîêàçàíèÿ (â ðåâìàòîëîãèè) Ìàáòåðà (ðèòóêñèìàá)Àíòèòåëà ê ÑD20 ðåöåïòîðàì ÐÀ, âàñêóëèòû Ðåìèêåéä (èíôëèêñèìàá) Àíòèòåëà ê ÔÍÎ-àëüôàÐÀ, ÁÊ, â ò.÷. ó äåòåé, ßÊ, ÀÑ, ÏÀ, Ïñîðèàç Ýíáðåë (Ýòàíýðöåïò)Èíãèáèòîð ÔÍÎ-àëüôàÐÀ, ÀÑ, ÏÀ, ÞÈÀ, Ïñîðèàç Õóìèðà (àäàëèìóìàá)Àíòèòåëà ê ÔÍÎ-àëüôàÐÀ, ÁÊ, ßÊ, ÀÑ, ÏÀ, Ïñîðèàç Îðåíñèÿ (Àáàòàñåïò)Ìîäóëÿòîð CD28 ðåöåïòîðîâ ÐÀ, ÞÈÀ Ñèìï

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U. S. Food and Drug Administration. Biosimilars. Available from: https:// goo.gl/Xy3HsL.
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    Íà ìèðîâûõ ðûíêàõ ïðåäñòàâëåíî îêîëî 20 áèîàíàëîãîâ äëÿ òåðàïèè ðåâìàòîèäíîãî àðòðèòà (ÐÀ), àíêèëîçèðóþùåãî ñïîíäèëèòà (ÀÑ), ïñîðèàòè÷åñêîãî àðòðèòà (ÏñÀ), ïñîðèàçà (ÏÑ), áîëåçíè Êðîíà (ÁÊ) è ÿçâåííîãî êîëèòà (ßÊ)
    Exact
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    . ÐÅÃÓËßÒÎÐÍÛÅ ÏÎÄÕÎÄÛ Ê ÏÐÈÇÍÀÍÈÞ ÁÈÎÀÍÀËÎÃÈ×ÍÎÑÒÈ Åâðîïåéñêèì àãåíòñòâîì ïî ëåêàðñòâåííûì ñðåäñòâàì (European Medicines Agency, ÅÌÀ) â 2005 ãîäó â îïóáëèêîâàííîì ðóêîâîäñòâå áûëà îáîñíîâàíà êîíöåïöèÿ áèîàíàëîãè÷íîñòè [5].

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European Medicines Agency. Biosimilar Medicines. Available from: https:// goo.gl/JxefFK.
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    Íà ìèðîâûõ ðûíêàõ ïðåäñòàâëåíî îêîëî 20 áèîàíàëîãîâ äëÿ òåðàïèè ðåâìàòîèäíîãî àðòðèòà (ÐÀ), àíêèëîçèðóþùåãî ñïîíäèëèòà (ÀÑ), ïñîðèàòè÷åñêîãî àðòðèòà (ÏñÀ), ïñîðèàçà (ÏÑ), áîëåçíè Êðîíà (ÁÊ) è ÿçâåííîãî êîëèòà (ßÊ)
    Exact
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    . ÐÅÃÓËßÒÎÐÍÛÅ ÏÎÄÕÎÄÛ Ê ÏÐÈÇÍÀÍÈÞ ÁÈÎÀÍÀËÎÃÈ×ÍÎÑÒÈ Åâðîïåéñêèì àãåíòñòâîì ïî ëåêàðñòâåííûì ñðåäñòâàì (European Medicines Agency, ÅÌÀ) â 2005 ãîäó â îïóáëèêîâàííîì ðóêîâîäñòâå áûëà îáîñíîâàíà êîíöåïöèÿ áèîàíàëîãè÷íîñòè [5].

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Guidline on similar biological medicinal products. Available from: https:// goo.gl/XdoSRo.
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    ÐÅÃÓËßÒÎÐÍÛÅ ÏÎÄÕÎÄÛ Ê ÏÐÈÇÍÀÍÈÞ ÁÈÎÀÍÀËÎÃÈ×ÍÎÑÒÈ Åâðîïåéñêèì àãåíòñòâîì ïî ëåêàðñòâåííûì ñðåäñòâàì (European Medicines Agency, ÅÌÀ) â 2005 ãîäó â îïóáëèêîâàííîì ðóêîâîäñòâå áûëà îáîñíîâàíà êîíöåïöèÿ áèîàíàëîãè÷íîñòè
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    .  äðóãèõ ñòðàíàõ (Êàíàäå, ßïîíèè è Àâñòðàëèè) ýòà êîíöåïöèÿ ÿâèëàñü îñíîâîé äëÿ ñîçäàíèÿ ñîáñòâåííûõ ïîäõîäîâ [6].  2009 ãîäó ÂÎÇ ïóáëèêóåò ðóêîâîäñòâî ïî îöåíêå áèîàíàëîãè÷íîñòè ïðåïàðàòîâ [7], òðåáîâàíèÿ êîòîðîãî ñòàëè îñíîâîé ïðè ðàçðàáîòêå ïîäõîäîâ áèîàíàëîãè÷íîñòè â Êîðåå è ñòðàíàõ Ëàòèíñêîé Àìåðèêè [8].

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Taylor L. Over 700 biosimilars now in development worldwide: report. Pharma Times digital. 30 September, 2014. Available from: https:// goo.gl/2hzMGT.
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    ÐÅÃÓËßÒÎÐÍÛÅ ÏÎÄÕÎÄÛ Ê ÏÐÈÇÍÀÍÈÞ ÁÈÎÀÍÀËÎÃÈ×ÍÎÑÒÈ Åâðîïåéñêèì àãåíòñòâîì ïî ëåêàðñòâåííûì ñðåäñòâàì (European Medicines Agency, ÅÌÀ) â 2005 ãîäó â îïóáëèêîâàííîì ðóêîâîäñòâå áûëà îáîñíîâàíà êîíöåïöèÿ áèîàíàëîãè÷íîñòè [5].  äðóãèõ ñòðàíàõ (Êàíàäå, ßïîíèè è Àâñòðàëèè) ýòà êîíöåïöèÿ ÿâèëàñü îñíîâîé äëÿ ñîçäàíèÿ ñîáñòâåííûõ ïîäõîäîâ
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    .  2009 ãîäó ÂÎÇ ïóáëèêóåò ðóêîâîäñòâî ïî îöåíêå áèîàíàëîãè÷íîñòè ïðåïàðàòîâ [7], òðåáîâàíèÿ êîòîðîãî ñòàëè îñíîâîé ïðè ðàçðàáîòêå ïîäõîäîâ áèîàíàëîãè÷íîñòè â Êîðåå è ñòðàíàõ Ëàòèíñêîé Àìåðèêè [8].

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Guidelines on evaluation of similar biotherapeutic products. Available from: https:// goo.gl/dFbGwD.
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    ÏÐÈÇÍÀÍÈÞ ÁÈÎÀÍÀËÎÃÈ×ÍÎÑÒÈ Åâðîïåéñêèì àãåíòñòâîì ïî ëåêàðñòâåííûì ñðåäñòâàì (European Medicines Agency, ÅÌÀ) â 2005 ãîäó â îïóáëèêîâàííîì ðóêîâîäñòâå áûëà îáîñíîâàíà êîíöåïöèÿ áèîàíàëîãè÷íîñòè [5].  äðóãèõ ñòðàíàõ (Êàíàäå, ßïîíèè è Àâñòðàëèè) ýòà êîíöåïöèÿ ÿâèëàñü îñíîâîé äëÿ ñîçäàíèÿ ñîáñòâåííûõ ïîäõîäîâ [6].  2009 ãîäó ÂÎÇ ïóáëèêóåò ðóêîâîäñòâî ïî îöåíêå áèîàíàëîãè÷íîñòè ïðåïàðàòîâ
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    , òðåáîâàíèÿ êîòîðîãî ñòàëè îñíîâîé ïðè ðàçðàáîòêå ïîäõîäîâ áèîàíàëîãè÷íîñòè â Êîðåå è ñòðàíàõ Ëàòèíñêîé Àìåðèêè [8]. Òàáëèöà 1 ÁÈÎËÎÃÈ×ÅÑÊÈÅ ÏÐÅÏÀÐÀÒÛ ÄËß ËÅ×ÅÍÈß ÐÅÂÌÀÒÈ×ÅÑÊÈÕ ÇÀÁÎËÅÂÀÍÈÉ [2] Ïðåïàðàò (ÌÍÍ)Ìåõàíèçì äåéñòâèÿÏîêàçàíèÿ (â ðåâìàòîëîãèè) Ìàáòåðà (ðèòóêñèìàá)Àíòèòåëà ê ÑD20 ðåöåïòîðàì ÐÀ, âàñêóëèòû Ðåìèêåéä (èíôëèêñèìàá) Àíòèòåëà ê ÔÍÎ-àëüôàÐÀ, ÁÊ, â ò.÷. ó äåòåé, ßÊ, ÀÑ, ÏÀ,

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    Â ðóêîâîäñòâå ÂÎÇ óêàçàíî, ÷òî äëÿ ýêñòðàïîëÿöèè ïîêàçàíèé íà áèîàíàëîã íåîáõîäèìî ïðîâîäèòü èññëåäîâàíèå íà ïîïóëÿöèè ñ íàèáîëåå âûñîêèì ðèñêîì èììóííîãî îòâåòà, ÷òî íå âñåãäà ñîâïàäàåò ñ ïîïóëÿöèåé, íàèáîëåå ÷óâñòâèòåëüíîé ê ýôôåêòó
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    . Ðåãóëèðóþùèå îðãàíû òðåáóþò âêëþ÷åíèÿ äîñòàòî÷íî ÷óâñòâèòåëüíûõ êîíå÷íûõ òî÷åê, òàê êàê èõ âûáîð â èññëåäîâàíèÿõ, ïîäòâåðæäàþùèõ áèîàíàëîãè÷íîñòü, ÿâëÿåòñÿ êðàéíå âàæíûì âîïðîñîì [20]. Êîíå÷íûå òî÷êè, îñíîâàííûå íà íåïðåðûâíûõ ïîêàçàòåëÿõ â ñðàâíåíèè ñ äèõîòîìè÷åñêèìè, îáû÷íî áîëåå ÷óâñòâèòåëüíû.

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Putrik P, Ramiro S, Kvien TK, Sokka T, Pavlova M, Uhlig T, et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis. 2014; 73(1): 198–206.
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     äðóãèõ ñòðàíàõ (Êàíàäå, ßïîíèè è Àâñòðàëèè) ýòà êîíöåïöèÿ ÿâèëàñü îñíîâîé äëÿ ñîçäàíèÿ ñîáñòâåííûõ ïîäõîäîâ [6].  2009 ãîäó ÂÎÇ ïóáëèêóåò ðóêîâîäñòâî ïî îöåíêå áèîàíàëîãè÷íîñòè ïðåïàðàòîâ [7], òðåáîâàíèÿ êîòîðîãî ñòàëè îñíîâîé ïðè ðàçðàáîòêå ïîäõîäîâ áèîàíàëîãè÷íîñòè â Êîðåå è ñòðàíàõ Ëàòèíñêîé Àìåðèêè
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    . Òàáëèöà 1 ÁÈÎËÎÃÈ×ÅÑÊÈÅ ÏÐÅÏÀÐÀÒÛ ÄËß ËÅ×ÅÍÈß ÐÅÂÌÀÒÈ×ÅÑÊÈÕ ÇÀÁÎËÅÂÀÍÈÉ [2] Ïðåïàðàò (ÌÍÍ)Ìåõàíèçì äåéñòâèÿÏîêàçàíèÿ (â ðåâìàòîëîãèè) Ìàáòåðà (ðèòóêñèìàá)Àíòèòåëà ê ÑD20 ðåöåïòîðàì ÐÀ, âàñêóëèòû Ðåìèêåéä (èíôëèêñèìàá) Àíòèòåëà ê ÔÍÎ-àëüôàÐÀ, ÁÊ, â ò.÷. ó äåòåé, ßÊ, ÀÑ, ÏÀ, Ïñîðèàç Ýíáðåë (Ýòàíýðöåïò)Èíãèáèòîð ÔÍÎ-àëüôàÐÀ, ÀÑ, ÏÀ, ÞÈÀ, Ïñîðèàç Õóìèðà (àäàëèìóìàá)Àíòèòåëà ê ÔÍÎ-àëüôàÐÀ, ÁÊ, ßÊ

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    Ñèìçèÿ (öåðòîëèçóìàá)Èíãèáèòîð ÔÍÎ-àëüôàÐÀ, ÀÑ, ÁÊ, ÏÀ Áåíëèñòà (Áåëèìóáàá)Àíòèòåëà ê BlySÑÊ Ïîçäíåå ïîíÿòèå áèîàíàëîãè÷íûõ ïðåïàðàòîâ áûëî âêëþ÷åíî â íîðìàòèâíóþ äîêóìåíòàöèþ Óïðàâëåíèÿ ïî êîíòðîëþ çà êà÷åñòâîì ïðîäóêòîâ ïèòàíèÿ è ëåêàðñòâåííûõ ñðåäñòâ ÑØÀ (Food and Drug Administration, FDA)
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    . Äî 2010 ãîäà â ÑØÀ áèîàíàëîãè íå âûäåëÿëèñü â îòäåëüíóþ ãðóïïó ËÏ, è òðåáîâàíèÿ ê íèì ñîäåðæàëèñü â ðàçäåëå 505 Ôåäåðàëüíîãî çàêîíà î ïèùåâûõ ïðîäóêòàõ, ëåêàðñòâåííûõ ñðåäñòâàõ è êîñìåòèêå (Food, Drug and Cosmetic Act, FDC Act) [10], ñîäåðæàùèì òðåáîâàíèÿ ê íîâûì ïðåïàðàòàì, âêëþ÷àÿ ïðîñòûå ïðîòåèíû, âûäåëåííûå èç ãðóïïû ñëîæíûõ áèîëîãè÷åñêèõ ïðåïàðàòîâ.

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Woodcock J. Biosimilar implementation: a progress report from FDA. 2015. Available from: http:// www.fda.gov/NewsEvents/Testimony/ucm463036.htm.
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    Ñèìçèÿ (öåðòîëèçóìàá)Èíãèáèòîð ÔÍÎ-àëüôàÐÀ, ÀÑ, ÁÊ, ÏÀ Áåíëèñòà (Áåëèìóáàá)Àíòèòåëà ê BlySÑÊ Ïîçäíåå ïîíÿòèå áèîàíàëîãè÷íûõ ïðåïàðàòîâ áûëî âêëþ÷åíî â íîðìàòèâíóþ äîêóìåíòàöèþ Óïðàâëåíèÿ ïî êîíòðîëþ çà êà÷åñòâîì ïðîäóêòîâ ïèòàíèÿ è ëåêàðñòâåííûõ ñðåäñòâ ÑØÀ (Food and Drug Administration, FDA)
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    . Äî 2010 ãîäà â ÑØÀ áèîàíàëîãè íå âûäåëÿëèñü â îòäåëüíóþ ãðóïïó ËÏ, è òðåáîâàíèÿ ê íèì ñîäåðæàëèñü â ðàçäåëå 505 Ôåäåðàëüíîãî çàêîíà î ïèùåâûõ ïðîäóêòàõ, ëåêàðñòâåííûõ ñðåäñòâàõ è êîñìåòèêå (Food, Drug and Cosmetic Act, FDC Act) [10], ñîäåðæàùèì òðåáîâàíèÿ ê íîâûì ïðåïàðàòàì, âêëþ÷àÿ ïðîñòûå ïðîòåèíû, âûäåëåííûå èç ãðóïïû ñëîæíûõ áèîëîãè÷åñêèõ ïðåïàðàòîâ.

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    Òàê, íàïðèìåð, ÷àñòîòà îòâåòà íà îïðåäåëåííóþ òåðàïèþ ó ìåòîòðåêñàòðåçèñòåíòíûõáîëüíûõ ÐÀ ñóùåñòâåííî âàðüèðóåò.  îïðåäåëåííûõ ñëó÷àÿõ FDA ïîçâîëÿåò àñèììåòðè÷íî ðàñøèðÿòü ãðàíèöó îòñóòñòâèÿ ïðåâîñõîäñòâà îòíîñèòåëüíî ãðàíèöû íå ìåíüøåé ýôôåêòèâíîñòè
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    . Ïðåäïî÷òåíèþ äèçàéíà íå ìåíüøåé ýôôåêòèâíîñòè, îñíîâàííîìó íà ìåíüøåé ÷èñëåííîñòè, ïðåïÿòñòâóåò íåâîçìîæíîñòü èñêëþ÷åíèÿ áîëåå âûñîêîé àêòèâíîñòè áèîàíàëîãà, ÷òî ìîæåò ïðèâîäèòü ê áîëåå âûñîêîé ÷àñòîòå íåæåëàòåëüíûõ ÿâëåíèé è áèîàíàëîã íå ìîæåò áûòü ïðèçíàí òàêîâûì, à äîëæåí ðàññìàòðèâàòüñÿ êàê áèîëîãè÷åñêèé ïðåïàðàò ñ áîëåå âûñîêîé àêòèâíîñòüþ è íåîáõîäèìîñòüþ áîëåå òùàòåëüíîãî êëèíè÷åñêîãî èçó

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    Êëèíè÷åñêàÿ çíà÷èìîñòü ãðàíèö ýêâèâàëåíòíîñòè äîëæíà áûòü ïîäðîáíî îáñóæäåíà â êîíòåêñòå ñîâîêóïíîñòè äàííûõ ïî ñðàâíåíèþ áèîàíàëîãà ñ ðåôåðåíòíûì ïðåïàðàòîì. Íàïðèìåð, äëÿ áèîàíàëîãà èíôëèêñèìàáà (Ðåìñèìà/Èíôëåêòðà/Ôëàììýãèñ) áûëà îáîñíîâàíà ðàçðàáîò÷èêîì ãðàíèöà 15 % äëÿ îöåíêè îòâåòà ïî ACR20 íà 30-é íåäåëå òåðàïèè
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    [9, 16]
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    . Ýòà ãðàíèöà áûëà ñîãëàñîâàíà ñ ÅÌÀ è îñíîâàíà íà ðåçóëüòàòàõ ìàòåìàòè÷åñêîãî àíàëèçà, îñíîâó êîòîðîãî ñîñòàâèëî èññëåäîâàíèå ATTRACT [43]. Îíà ñîñòàâëÿëà îêîëî 50 % îò ðàçëè÷èÿ òî÷å÷íûõ çíà÷åíèé ÷àñòîò ãðóïïû òåðàïèè èíôëèêñèìàáîì â ñîîòâåòñòâóþùåì ðåæèìå è ïëàöåáî.

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    Ïîêàçàòåëüíî, ÷òî ãðàíèöà â 15 % áûëà ïðèíÿòà ÅÌÀ (Êîìèòåòîì ïî ëåêàðñòâåííûì ñðåäñòâàì äëÿ ïðèìåíåíèÿ ó ÷åëîâåêà — Committee for Medicinal Products for Human Use, CHMP) ïðè ó÷åòå âñåé ñîâîêóïíîñòè ïðåäûäóùèõ èññëåäîâàíèé, ïîäòâåðæäàþùèõ áèîàíàëîãè÷íîñòü
    Exact
    [9, 16]
    Suffix
    . Òàêàÿ æå ãðàíèöà ýêâèâàëåíòíîñòè (15 %) áûëà èñïîëüçîâàíà â èññëåäîâàíèè III ôàçû áèîàíàëîãà èíôëèêñèìàáà êîìïàíèè «Samsung Bioepis »[44] è â èññëåäîâàíèè áèîàíàëîãà ýòàíåðöåïòà ýòîé æå êîìïàíèè [45]. ×èñëåííîñòü äîáðîâîëüöåâ, ó÷àñòâóþùèõ â èññëåäîâàíèè, ïîìèìî ïëàíèðóåìîé ñòàòèñòè÷åñêîé çíà÷èìîñòè, ìîùíîñòè è ÷àñòîòû âûáûâàíèÿ íàïðÿìóþ çàâèñèò îò ãðàíèöû ýêâèâàëåíòíîñòè.

10
FederalFood,DrugandCosmeticAct.Availablefrom: https:// goo.gl/4xHjd7.
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    Äî 2010 ãîäà â ÑØÀ áèîàíàëîãè íå âûäåëÿëèñü â îòäåëüíóþ ãðóïïó ËÏ, è òðåáîâàíèÿ ê íèì ñîäåðæàëèñü â ðàçäåëå 505 Ôåäåðàëüíîãî çàêîíà î ïèùåâûõ ïðîäóêòàõ, ëåêàðñòâåííûõ ñðåäñòâàõ è êîñìåòèêå (Food, Drug and Cosmetic Act, FDC Act)
    Exact
    [10]
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    , ñîäåðæàùèì òðåáîâàíèÿ ê íîâûì ïðåïàðàòàì, âêëþ÷àÿ ïðîñòûå ïðîòåèíû, âûäåëåííûå èç ãðóïïû ñëîæíûõ áèîëîãè÷åñêèõ ïðåïàðàòîâ.  ñâîþ î÷åðåäü, ñëîæíûå ïðîòåèíû ðàññìàòðèâàëèñü îòäåëüíî â ñîîòâåòñòâèè ñ ðàçäåëîì 351 Çàêîíà î ñëóæáå çäðàâîîõðàíåíèÿ (Public Health Service Act, ÐÍSA) [11].

11
Public Health Service Act. Available from: https:// legcounsel.house.gov/Comps/PHSA-merged.pdf.
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    Ôåäåðàëüíîãî çàêîíà î ïèùåâûõ ïðîäóêòàõ, ëåêàðñòâåííûõ ñðåäñòâàõ è êîñìåòèêå (Food, Drug and Cosmetic Act, FDC Act) [10], ñîäåðæàùèì òðåáîâàíèÿ ê íîâûì ïðåïàðàòàì, âêëþ÷àÿ ïðîñòûå ïðîòåèíû, âûäåëåííûå èç ãðóïïû ñëîæíûõ áèîëîãè÷åñêèõ ïðåïàðàòîâ.  ñâîþ î÷åðåäü, ñëîæíûå ïðîòåèíû ðàññìàòðèâàëèñü îòäåëüíî â ñîîòâåòñòâèè ñ ðàçäåëîì 351 Çàêîíà î ñëóæáå çäðàâîîõðàíåíèÿ (Public Health Service Act, ÐÍSA)
    Exact
    [11]
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    .  2010 ãîäó â ÑØÀ áûë ïðèíÿò Çàêîí î öåíîâîé êîíêóðåíöèè è èííîâàöèÿõ áèîëîãè÷åñêèõ ïðåïàðàòîâ (Biologics Price Competition and Innovation Act, BPCIA) [12].  ñîîòâåòñòâèè ñ òðåáîâàíèÿìè óêàçàííîãî çàêîíà (ðàçäåë 351(k)) ñîêðàùåíà íåîáõîäèìàÿ ïðîãðàììà äëÿ ðåãèñòðàöèè áèîëîãè÷åñêèõ ïðåïàðàòîâ, ïîäòâåðäèâøèõ ñâîþ áèîàíàëîãè÷íîñòü èëè âçàèìîçàìåíÿåìîñòü ïî îòíîøåíèþ ê áèîëîãè÷åñêîìó ëåêàðñòâåí

12
Implementation of the Biologics Price Competition and Innovation Act of 2009. Available from: https:// goo.gl/Ai3RUq.
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     ñâîþ î÷åðåäü, ñëîæíûå ïðîòåèíû ðàññìàòðèâàëèñü îòäåëüíî â ñîîòâåòñòâèè ñ ðàçäåëîì 351 Çàêîíà î ñëóæáå çäðàâîîõðàíåíèÿ (Public Health Service Act, ÐÍSA) [11].  2010 ãîäó â ÑØÀ áûë ïðèíÿò Çàêîí î öåíîâîé êîíêóðåíöèè è èííîâàöèÿõ áèîëîãè÷åñêèõ ïðåïàðàòîâ (Biologics Price Competition and Innovation Act, BPCIA)
    Exact
    [12]
    Suffix
    .  ñîîòâåòñòâèè ñ òðåáîâàíèÿìè óêàçàííîãî çàêîíà (ðàçäåë 351(k)) ñîêðàùåíà íåîáõîäèìàÿ ïðîãðàììà äëÿ ðåãèñòðàöèè áèîëîãè÷åñêèõ ïðåïàðàòîâ, ïîäòâåðäèâøèõ ñâîþ áèîàíàëîãè÷íîñòü èëè âçàèìîçàìåíÿåìîñòü ïî îòíîøåíèþ ê áèîëîãè÷åñêîìó ëåêàðñòâåííîìó ðåôåðåíòíîìó ïðåïàðàòó, çàðåãèñòðèðîâàííîìó FDA [13].

13
Biosimilars: Questions and answers regarding the implementation of the Biologics Price Competition and Innovation Act of 2009 [Internet]. Available from: http://www.pharmadvisor.ru/document/ tr3698 (in Russian).
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     ñîîòâåòñòâèè ñ òðåáîâàíèÿìè óêàçàííîãî çàêîíà (ðàçäåë 351(k)) ñîêðàùåíà íåîáõîäèìàÿ ïðîãðàììà äëÿ ðåãèñòðàöèè áèîëîãè÷åñêèõ ïðåïàðàòîâ, ïîäòâåðäèâøèõ ñâîþ áèîàíàëîãè÷íîñòü èëè âçàèìîçàìåíÿåìîñòü ïî îòíîøåíèþ ê áèîëîãè÷åñêîìó ëåêàðñòâåííîìó ðåôåðåíòíîìó ïðåïàðàòó, çàðåãèñòðèðîâàííîìó FDA
    Exact
    [13]
    Suffix
    . BPCIA ïåðåñìàòðèâàåò îïðåäåëåíèå áèîëîãè÷åñêîãî ïðåïàðàòà â PHSA, âêëþ÷àÿ ïðîòåèíû (çà èñêëþ÷åíèåì õèìè÷åñêè ñèíÒàáëèöà 2 ÀÍÀËÈÒÈ×ÅÑÊÈÅ, ÔÓÍÊÖÈÎÍÀËÜÍÛÅ È ÈÍÛÅ ÄÎÊËÈÍÈ×ÅÑÊÈÅ ÈÑÑËÅÄÎÂÀÍÈß ÄËß ÁÈÎÀÍÀËÎÃÀ ÈÍÔËÈÊÑÈÌÀÁÀ [16] Ïàðàìåòðû àíàëèçàÌåòîäû àíàëèçà Ôèçèêî-õèìè÷åñêèå ñâîéñòâà Ïåðâè÷íàÿ ñòðóêòóðà Àìèíîêèñëîòíûé àíàëèç, ïåïòèäíîå êàðòèðîâàíèå (LC-MS) â êîìáèíàöèè ñ òàíäåìíîé ìàññ-ñïåêòðîìåò

14
Christl L. Biologics Price Competition and Innovation Act of 2009: FDA’s overview of the regulatory guidance for the development and approval of biosimilar products in the US. Available from: https:// goo.gl/iKfcq8.
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    Ïðèìå÷àíèå:ÀÇÖÒ — àíòèòåëî-çàâèñèìàÿ öèòîòîêñè÷íîñòü; ÁÊ — áîëåçíü Êðîíà; ÊÇÖÒ — êîìïëåìåíò-çàâèñèìàÿ öèòîòîêñè÷íîñòü. òåçèðîâàííûõ ïîëèïåïòèäîâ), è îïðåäåëÿåò áèîàíàëîã êàê «áèîëîãè÷åñêèé ïðîäóêò, âûñîêî ñõîäíûé ðåôåðåíòíîìó, íåñìîòðÿ íà íåçíà÷èòåëüíûå ðàçëè÷èÿ â êëèíè÷åñêè íåàêòèâíûõ ñòðóêòóðíûõ êîìïîíåíòàõ ïðè îòñóòñòâèè êëèíè÷åñêè çíà÷èìûõ ðàçëè÷èé â áåçîïàñíîñòè, êà÷åñòâå è ýôôåêòèâíîñòè »
    Exact
    [14]
    Suffix
    . Òðåáîâàíèÿ ê îöåíêå áèîàíàëîãîâ â Ðîññèéñêîé Ôåäåðàöèè ïðåäñòàâëåíû â «Ðóêîâîäñòâå ïî ýêñïåðòèçå ëåêàðñòâåííûõ ñðåäñòâ», îïóáëèêîâàííîì ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè [15]. Ýòè òðåáîâàíèÿ ñîîòâåòñòâóþò ïîäõîäàì ÅÌÀ ê ïðèçíàíèþ áèîàíàëîãè÷íîñòè ËÏ.

15
Guidance on evaluation of medicines. V. IV. Moscow: Poligraf-Plus; 2014 (in Russian).
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    «áèîëîãè÷åñêèé ïðîäóêò, âûñîêî ñõîäíûé ðåôåðåíòíîìó, íåñìîòðÿ íà íåçíà÷èòåëüíûå ðàçëè÷èÿ â êëèíè÷åñêè íåàêòèâíûõ ñòðóêòóðíûõ êîìïîíåíòàõ ïðè îòñóòñòâèè êëèíè÷åñêè çíà÷èìûõ ðàçëè÷èé â áåçîïàñíîñòè, êà÷åñòâå è ýôôåêòèâíîñòè »[14]. Òðåáîâàíèÿ ê îöåíêå áèîàíàëîãîâ â Ðîññèéñêîé Ôåäåðàöèè ïðåäñòàâëåíû â «Ðóêîâîäñòâå ïî ýêñïåðòèçå ëåêàðñòâåííûõ ñðåäñòâ», îïóáëèêîâàííîì ÔÃÁÓ «ÍÖÝÑÌÏ »Ìèíçäðàâà Ðîññèè
    Exact
    [15]
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    . Ýòè òðåáîâàíèÿ ñîîòâåòñòâóþò ïîäõîäàì ÅÌÀ ê ïðèçíàíèþ áèîàíàëîãè÷íîñòè ËÏ. Íåîáõîäèìûå òðåáîâàíèÿ ê äîêëèíè÷åñêèì èññëåäîâàíèÿì, ôóíêöèîíàëüíûì è èíûì õàðàêòåðèñòèêàì íà ïðèìåðå áèîàíàëîãà èíôëèêñèìàáà, ïðåäñòàâëåíû â òàáëèöå 2.

16
Goel N, Chance K. The biosimilar landscape: a systematic review of its current status. Arthritis Rheum. 2014; 66(Suppl 11): S662.
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    BPCIA ïåðåñìàòðèâàåò îïðåäåëåíèå áèîëîãè÷åñêîãî ïðåïàðàòà â PHSA, âêëþ÷àÿ ïðîòåèíû (çà èñêëþ÷åíèåì õèìè÷åñêè ñèíÒàáëèöà 2 ÀÍÀËÈÒÈ×ÅÑÊÈÅ, ÔÓÍÊÖÈÎÍÀËÜÍÛÅ È ÈÍÛÅ ÄÎÊËÈÍÈ×ÅÑÊÈÅ ÈÑÑËÅÄÎÂÀÍÈß ÄËß ÁÈÎÀÍÀËÎÃÀ ÈÍÔËÈÊÑÈÌÀÁÀ
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    Ïàðàìåòðû àíàëèçàÌåòîäû àíàëèçà Ôèçèêî-õèìè÷åñêèå ñâîéñòâà Ïåðâè÷íàÿ ñòðóêòóðà Àìèíîêèñëîòíûé àíàëèç, ïåïòèäíîå êàðòèðîâàíèå (LC-MS) â êîìáèíàöèè ñ òàíäåìíîé ìàññ-ñïåêòðîìåòðèåé (MS/MS), ïåïòèäíîå êàðòèðîâàíèå (HPLC), N-êîíöåâàÿ ïîñëåäîâàòåëüíîñòü, Ñ-êîíöåâàÿ ïîñëåäîâàòåëüíîñòü, îïðåäåëåíèå ìàññû Ñòðóêòóðà âûñîêîãî ïîðÿäêà Äèñóëüôèäíûå ñâÿçè, àíàëèç ñâîáîäíîãî òèîëà, èíôðàêðàñíàÿ ñïåêòðîñêîïèÿ ñ

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    Êëèíè÷åñêàÿ çíà÷èìîñòü ãðàíèö ýêâèâàëåíòíîñòè äîëæíà áûòü ïîäðîáíî îáñóæäåíà â êîíòåêñòå ñîâîêóïíîñòè äàííûõ ïî ñðàâíåíèþ áèîàíàëîãà ñ ðåôåðåíòíûì ïðåïàðàòîì. Íàïðèìåð, äëÿ áèîàíàëîãà èíôëèêñèìàáà (Ðåìñèìà/Èíôëåêòðà/Ôëàììýãèñ) áûëà îáîñíîâàíà ðàçðàáîò÷èêîì ãðàíèöà 15 % äëÿ îöåíêè îòâåòà ïî ACR20 íà 30-é íåäåëå òåðàïèè
    Exact
    [9, 16]
    Suffix
    . Ýòà ãðàíèöà áûëà ñîãëàñîâàíà ñ ÅÌÀ è îñíîâàíà íà ðåçóëüòàòàõ ìàòåìàòè÷åñêîãî àíàëèçà, îñíîâó êîòîðîãî ñîñòàâèëî èññëåäîâàíèå ATTRACT [43]. Îíà ñîñòàâëÿëà îêîëî 50 % îò ðàçëè÷èÿ òî÷å÷íûõ çíà÷åíèé ÷àñòîò ãðóïïû òåðàïèè èíôëèêñèìàáîì â ñîîòâåòñòâóþùåì ðåæèìå è ïëàöåáî.

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    Ïîêàçàòåëüíî, ÷òî ãðàíèöà â 15 % áûëà ïðèíÿòà ÅÌÀ (Êîìèòåòîì ïî ëåêàðñòâåííûì ñðåäñòâàì äëÿ ïðèìåíåíèÿ ó ÷åëîâåêà — Committee for Medicinal Products for Human Use, CHMP) ïðè ó÷åòå âñåé ñîâîêóïíîñòè ïðåäûäóùèõ èññëåäîâàíèé, ïîäòâåðæäàþùèõ áèîàíàëîãè÷íîñòü
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    . Òàêàÿ æå ãðàíèöà ýêâèâàëåíòíîñòè (15 %) áûëà èñïîëüçîâàíà â èññëåäîâàíèè III ôàçû áèîàíàëîãà èíôëèêñèìàáà êîìïàíèè «Samsung Bioepis »[44] è â èññëåäîâàíèè áèîàíàëîãà ýòàíåðöåïòà ýòîé æå êîìïàíèè [45]. ×èñëåííîñòü äîáðîâîëüöåâ, ó÷àñòâóþùèõ â èññëåäîâàíèè, ïîìèìî ïëàíèðóåìîé ñòàòèñòè÷åñêîé çíà÷èìîñòè, ìîùíîñòè è ÷àñòîòû âûáûâàíèÿ íàïðÿìóþ çàâèñèò îò ãðàíèöû ýêâèâàëåíòíîñòè.

17
Aerts LA, De Smet K, Reichmann G, van der Laan JW, Schneider CK. Biosimilars entering the clinic without animal studies. A paradigm shift in the European Union. MAbs 2014; 6(5): 1155–62.
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    Ôîðìàëèçîâàííûå ðàçëè÷èÿ â òðåáîâàíèÿõ ê âîñïðîèçâåäåííûì è áèîàíàëîãè÷íûì ïðåïàðàòàì ñõåìàòè÷íî ïðåäñòàâëåíû â òàáëèöå 3. Àíàëèç èññëåäîâàíèé áèîàíàëîãîâ ñâÿçàí ñ ôåíîìåíîì ñäâèãà ãðàíèö êðèòè÷íûõ ïîêàçàòåëåé (shift paradigm) â ðàçíûõ ñòðàíàõ
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    .  ñâÿçè ñ ýòèì âîçìîæíî âîçíèêíîâåíèå ïðîáëåì ñ ïðèçíàíèåì ýòàëîíîâ äëÿ ñðàâíèòåëüíûõ èññëåäîâàíèé ýòèõ ïðåïàðàòîâ. ÄÈÇÀÉÍ ÏÎÄÒÂÅÐÆÄÀÞÙÈÕ ÊËÈÍÈ×ÅÑÊÈÕ ÈÑÑËÅÄÎÂÀÍÈÉ Â êà÷åñòâå îñíîâíîãî ïîêàçàíèÿ äëÿ îöåíêè â ïîäòâåðæäàþùåì èññëåäîâàíèè îáû÷íî âûáèðàþò íàèáîëåå ÷óâñòâèòåëüíîå, òî åñòü òî, â ñëó÷àå êîòîðîãî ïðîäåìîíñòðèðîâàí ìàêñèìàëüíûé ýôôåêò (effect size) äëÿ îðèãèíàëüíîãî ïðîäóêòà.

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Lee H. Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars? AAPS J 2014; 16(1): 22–6.
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    íåîáõîäèìû, íàïðèìåð, äëÿ îöåíêè ðèñêîâ íåæåëàòåëüíûõ ÿâëåíèé è äîïîëíèòåëüíîé îöåíêè èììóíîãåííîñòè Èññëåäîâàíèÿ ó äåòåéÍå íóæíû ÑØÀ íåîáõîäèìîñòü ïåäèàòðè÷åñêèõ èññëåäîâàíèé äîëæíà îáñóæäàòüñÿ ñ FDA, îäíàêî â íèõ íåò íåîáõîäèìîñòè, åñëè äîêàçàíà âçàèìîçàìåíÿåìîñòü åãî ðåôåðåíòó. EMA íå òðåáóåò ïðîâåäåíèÿ ïåäèàòðè÷åñêèõ èññëåäîâàíèé (ÔÍÎ) íàèáîëåå ÷óâñòâèòåëüíûì ïîêàçàíèåì ÿâëÿåòñÿ ïñîðèàç
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    [18]
    Suffix
    .  òî æå âðåìÿ èíôëèêñèìàá èñïîëüçóåòñÿ áîëåå ðåäêî, ÷åì èíûå áèîëîãè÷åñêèå ïðåïàðàòû äëÿ ëå÷åíèÿ ïñîðèàçà, è â ïðîãðàììû ðàçðàáîòêè áèîàíàëîãè÷íûõ ïðåïàðàòîâ ïîêàçàíèå «ïñîðèàç »íå âêëþ÷åíî [19].

19
Kimball AB, Leonardi C, Stahle M, Gulliwer W, Chevrier M, Fakharzadeh S, et al. Demography, baseline disease characteristics and treatment history of patients with psoriasis enrolled in a multicentre, prospective, disease-based registry (PSOLAR). Br J Dermatol.
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    EMA íå òðåáóåò ïðîâåäåíèÿ ïåäèàòðè÷åñêèõ èññëåäîâàíèé (ÔÍÎ) íàèáîëåå ÷óâñòâèòåëüíûì ïîêàçàíèåì ÿâëÿåòñÿ ïñîðèàç [18].  òî æå âðåìÿ èíôëèêñèìàá èñïîëüçóåòñÿ áîëåå ðåäêî, ÷åì èíûå áèîëîãè÷åñêèå ïðåïàðàòû äëÿ ëå÷åíèÿ ïñîðèàçà, è â ïðîãðàììû ðàçðàáîòêè áèîàíàëîãè÷íûõ ïðåïàðàòîâ ïîêàçàíèå «ïñîðèàç »íå âêëþ÷åíî
    Exact
    [19]
    Suffix
    . Â ðóêîâîäñòâå ÂÎÇ óêàçàíî, ÷òî äëÿ ýêñòðàïîëÿöèè ïîêàçàíèé íà áèîàíàëîã íåîáõîäèìî ïðîâîäèòü èññëåäîâàíèå íà ïîïóëÿöèè ñ íàèáîëåå âûñîêèì ðèñêîì èììóííîãî îòâåòà, ÷òî íå âñåãäà ñîâïàäàåò ñ ïîïóëÿöèåé, íàèáîëåå ÷óâñòâèòåëüíîé ê ýôôåêòó [7].

20
4; 171(1): 137–47. 20. European Medicines Agency. Guideline on similar biological medicinal products. 2014. Available from: https:// goo.gl/2X5hXM.
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    , ÷òî äëÿ ýêñòðàïîëÿöèè ïîêàçàíèé íà áèîàíàëîã íåîáõîäèìî ïðîâîäèòü èññëåäîâàíèå íà ïîïóëÿöèè ñ íàèáîëåå âûñîêèì ðèñêîì èììóííîãî îòâåòà, ÷òî íå âñåãäà ñîâïàäàåò ñ ïîïóëÿöèåé, íàèáîëåå ÷óâñòâèòåëüíîé ê ýôôåêòó [7]. Ðåãóëèðóþùèå îðãàíû òðåáóþò âêëþ÷åíèÿ äîñòàòî÷íî ÷óâñòâèòåëüíûõ êîíå÷íûõ òî÷åê, òàê êàê èõ âûáîð â èññëåäîâàíèÿõ, ïîäòâåðæäàþùèõ áèîàíàëîãè÷íîñòü, ÿâëÿåòñÿ êðàéíå âàæíûì âîïðîñîì
    Exact
    [20]
    Suffix
    . Êîíå÷íûå òî÷êè, îñíîâàííûå íà íåïðåðûâíûõ ïîêàçàòåëÿõ â ñðàâíåíèè ñ äèõîòîìè÷åñêèìè, îáû÷íî áîëåå ÷óâñòâèòåëüíû. Íàïðèìåð, èñïîëüçîâàíèå çíà÷åíèé DAS28 â ñðàâíåíèè ñ ACR20 êðèòåðèåì áîëåå îáîñíîâàíî ñ òî÷êè çðåíèÿ âåðîÿòíîñòè îáíàðóæåíèÿ ðàçëè÷èé, êàê è èñïîëüçîâàíèå ñðåäíåãî çíà÷åíèÿ PASI ïðè ïñîðèàçå áîëåå îáîñíîâàíî, ÷åì ÷àñòîòà îòâåòà ïî PASI 75 % [21].

21
Schmitz S, Adams R, Walsh C. The use of continuous data versus binary data in MTC models: A case study in rheumatoid arthritis. BMC Med Res Methodol 2012; (12): 167.
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  1. In-text reference with the coordinate start=13714
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    Íàïðèìåð, èñïîëüçîâàíèå çíà÷åíèé DAS28 â ñðàâíåíèè ñ ACR20 êðèòåðèåì áîëåå îáîñíîâàíî ñ òî÷êè çðåíèÿ âåðîÿòíîñòè îáíàðóæåíèÿ ðàçëè÷èé, êàê è èñïîëüçîâàíèå ñðåäíåãî çíà÷åíèÿ PASI ïðè ïñîðèàçå áîëåå îáîñíîâàíî, ÷åì ÷àñòîòà îòâåòà ïî PASI 75 %
    Exact
    [21]
    Suffix
    . Àíàëèç ïåðâè÷íûõ êîíå÷íûõ òî÷åê äîëæåí áûòü ñôîêóñèðîâàí íà äîçàõ, íàõîäÿùèõñÿ íà âîñõîäÿùåé ÷àñòè êðèâîé äîçà-ýôôåêò, òàê êàê èìåííî îíè áîëåå ÷óâñòâèòåëüíû ê îáíàðóæåíèþ ðàçëè÷èé, íåæåëè äîçû, íàõîäÿùèåñÿ íà ïëàòî ýòîé êðèâîé.

22
Lai Z, La Noce A. Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example. RMD Open 2016; 2(1): e000154.
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  1. In-text reference with the coordinate start=14076
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    Àíàëèç ïåðâè÷íûõ êîíå÷íûõ òî÷åê äîëæåí áûòü ñôîêóñèðîâàí íà äîçàõ, íàõîäÿùèõñÿ íà âîñõîäÿùåé ÷àñòè êðèâîé äîçà-ýôôåêò, òàê êàê èìåííî îíè áîëåå ÷óâñòâèòåëüíû ê îáíàðóæåíèþ ðàçëè÷èé, íåæåëè äîçû, íàõîäÿùèåñÿ íà ïëàòî ýòîé êðèâîé.  îòíîøåíèè âûáîðà íàèáîëåå ÷óâñòâèòåëüíîãî ïîêàçàíèÿ äëÿ îöåíêè òåðàïåâòè÷åñêîé ýêâèâàëåíòíîñòè ïîêàçàòåëåí ïðèìåð ñ àäàëèìóìàáîì
    Exact
    [22]
    Suffix
    . Ðàçëè÷èå ìåæäó ïëàöåáî è àäàëèìóìàáîì ìàêñèìàëüíî ïðè ëå÷åíèè ïñîðèàçà. Âåðîÿòíî, ýòî ñâÿçàíî ñ òåì, ÷òî ïðèìåíåíèå àäàëèìóìàáà â ýòîì ñëó÷àå, â îòëè÷èå îò ðåâìàòîäèäíîãî àðòðèòà, îñóùåñòâëÿåòñÿ â ðåæèìå ìîíîòåðàïèè (òàáë. 4).

23
Cohen SB, Genovese MC, Choy EH, Perez-Ruis F, Pablos JL, Zhang N, et al. Randomized, double-blind, phase 3 study of efficacy and safety of ABP 501 compared with adalimumab in subjects with moderate to severe rheumatoid arthritis. https:// goo.gl/qAg3Mv.
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  1. In-text reference with the coordinate start=15091
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     òî æå âðåìÿ ïñîðèàç ÿâëÿåòñÿ âåñüìà îáîñíîâàííûì ïîêàçàíèåì äëÿ äåìîíñòðàöèè áèîàíàëîãè÷íîñòè, ó÷èòûâàÿ áîëåå âûñîêóþ ÷óâñòâèòåëüíîñòü êðèòåðèåâ îöåíêè ýôôåêòèâíîñòè è áîëåå âûñîêèé èììóíîãåííûé ïîòåíöèàë (íåò ñîïóòñòâóþùåé òåðàïèè ìåòîòðåêñàòîì). Ýòî ïîêàçàíèå èñïîëüçóåòñÿ äëÿ êëèíè÷åñêîé ðàçðàáîòêè è äðóãèõ ïðåïàðàòîâ-èíãèáèòîðîâ ÔÍÎ
    Exact
    [23]
    Suffix
    . Ñëåäóåò îòìåòèòü, ÷òî äëèòåëüíî ïðèìåíÿåìûå áèîàíàëîãè òðåáóþò ïîëó÷åíèÿ äàííûõ ïî áåçîïàñíîñòè è èììóíîãåííîñòè íå ìåíåå ÷åì çà 12 ìåñÿöåâ [24, 25]. ÝÊÑÒÐÀÏÎËßÖÈß ÏÎÊÀÇÀÍÈÉ Îáû÷íî äîêàçàòåëüñòâà ýêâèâàëåíòíîñòè ïî îäíîìó èç ïîêàçàíèé â ðàìêàõ îñíîâíîãî èññëåäîâàíèÿ äîñòàòî÷íî äëÿ ýêñòðàïîëÿöèè ïîêàçàíèé ðåôåðåíòíîãî ïðåïàðàòà íà áèîàíàëîã.

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    Ðåãóëÿòîðíûå òðåáîâàíèÿ Àâñòðàëèè è Êàíàäû òàêæå óêàçûâàþò íà íåîáõîäèìîñòü ïðåäïî÷òåíèÿ äèçàéíà ýêâèâàëåíòíîñòè, îäíàêî äîïóñêàþò âîçìîæíîñòü ïðîâåäåíèÿ èññëåäîâàíèÿ íå ìåíüøåé ýôôåêòèâíîñòè â ñëó÷àå Òàáëèöà 5 ÈÑÑËÅÄÎÂÀÍÈß ÊËÈÍÈ×ÅÑÊÎÉ ÝÔÔÅÊÒÈÂÍÎÑÒÈ ÁÈÎÀÍÀËÎÃΠÀÄÀËÈÌÓÌÀÁÀ  ÌÈÐÅ
    Exact
    [23]
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    Íàèìåíîâàíèå êîìïàíèè Íàçâàíèå ïðåïàðàòàÏîêàçàíèå Íà÷àëî èññëåäîâàíèÿ×èñëî ïàöèåíòîâ Íîìåð èññëåäîâàíèÿ (NCT èëè EudraCT) AmgenABP-501Ïñîðèàç2013350NCT01970488 ÐÀ2013526NCT01970475 Boehringer Ingelheim BI 695501ÐÀ2014650NCT02137226 2012-002945-40 Fuji Film Kyowa Kirin Biologics FKB327ÐÀ2014600NCT02260791 2014-000109-11 PfizerPF-06410293ÐÀ2014560NCT02480153 2014-000352-29 Samsung BioepisSB5ÐÀ20144

24
Weinblatt ME, Keystone EC, Furst DE, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum. 2003; 48(1): 35–45.
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    Ýòî ïîêàçàíèå èñïîëüçóåòñÿ äëÿ êëèíè÷åñêîé ðàçðàáîòêè è äðóãèõ ïðåïàðàòîâ-èíãèáèòîðîâ ÔÍÎ [23]. Ñëåäóåò îòìåòèòü, ÷òî äëèòåëüíî ïðèìåíÿåìûå áèîàíàëîãè òðåáóþò ïîëó÷åíèÿ äàííûõ ïî áåçîïàñíîñòè è èììóíîãåííîñòè íå ìåíåå ÷åì çà 12 ìåñÿöåâ
    Exact
    [24, 25]
    Suffix
    . ÝÊÑÒÐÀÏÎËßÖÈß ÏÎÊÀÇÀÍÈÉ Îáû÷íî äîêàçàòåëüñòâà ýêâèâàëåíòíîñòè ïî îäíîìó èç ïîêàçàíèé â ðàìêàõ îñíîâíîãî èññëåäîâàíèÿ äîñòàòî÷íî äëÿ ýêñòðàïîëÿöèè ïîêàçàíèé ðåôåðåíòíîãî ïðåïàðàòà íà áèîàíàëîã. Ïîäõîäû ðåãóëÿòîðíûõ îðãàíîâ ê ýêñòðàïîëÿöèè äàííûõ ðàçëè÷íû.

25
Press relies, April 5, 2016. FDA approvesInflectra, a biosimilar to Remicade. Available from: https:// goo.gl/yrd6Em.
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  1. In-text reference with the coordinate start=15237
    Prefix
    Ýòî ïîêàçàíèå èñïîëüçóåòñÿ äëÿ êëèíè÷åñêîé ðàçðàáîòêè è äðóãèõ ïðåïàðàòîâ-èíãèáèòîðîâ ÔÍÎ [23]. Ñëåäóåò îòìåòèòü, ÷òî äëèòåëüíî ïðèìåíÿåìûå áèîàíàëîãè òðåáóþò ïîëó÷åíèÿ äàííûõ ïî áåçîïàñíîñòè è èììóíîãåííîñòè íå ìåíåå ÷åì çà 12 ìåñÿöåâ
    Exact
    [24, 25]
    Suffix
    . ÝÊÑÒÐÀÏÎËßÖÈß ÏÎÊÀÇÀÍÈÉ Îáû÷íî äîêàçàòåëüñòâà ýêâèâàëåíòíîñòè ïî îäíîìó èç ïîêàçàíèé â ðàìêàõ îñíîâíîãî èññëåäîâàíèÿ äîñòàòî÷íî äëÿ ýêñòðàïîëÿöèè ïîêàçàíèé ðåôåðåíòíîãî ïðåïàðàòà íà áèîàíàëîã. Ïîäõîäû ðåãóëÿòîðíûõ îðãàíîâ ê ýêñòðàïîëÿöèè äàííûõ ðàçëè÷íû.

26
Grabowski D, Henderson B, Lam D, Keystone EC, Thorne C, Jamal S, et al. Attitudes towards subsequent entry biologics/biosimilars: a survey of Canadian rheumatologists. Clin Rheumatol 2015; 34(8): 1427–33.
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    Îñíîâàíèåì ñòàëî îòñóòñòâèå äîêàçàòåëüñòâ êëèíè÷åñêîé ýêâèâàëåíòíîñòè ïðè ñóùåñòâîâàíèè ðàçëè÷èé â ìåõàíèçìå ðåàëèçàöèè êëèíè÷åñêîãî ýôôåêòà ïðè ïðèìåíåíèè èíôëèêñèìàáà ïðè âîñïàëèòåëüíûõ çàáîëåâàíèÿõ êèøå÷íèêà è âîñïàëèòåëüíûõ çàáîëåâàíèÿõ ñóñòàâîâ è ïñîðèàçå
    Exact
    [26]
    Suffix
    .  Àâñòðàëèè ïðåïàðàò çàðåãèñòðèðîâàí íà îñíîâå äàííûõ ÅÌÀ ïî âñåì ïîêàçàíèÿì, èìåþùèìñÿ ó Ðåìèêåéäà [27].  òî æå âðåìÿ â ßïîíèè âêëþ÷åíû â ïîêàçàíèÿ òîëüêî ÐÀ, ÁÊ è ßÊ [28]. Âàæíî îòìåòèòü, ÷òî â àïðåëå 2016 ãîäà FDA çàðåãèñòðèðîâàëî ýòîò áèîàíàëîã, ïîäàííûé äëÿ ðàññìîòðåíèÿ â FDA â 2014 ãîäó (ïîä òîðãîâûì íàèìåíîâàíèåì Èíôëåêòðà), ýêñòðàïîëèðóÿ âñå ïîêàçàíèÿ ðåôåðåíòíîãî ïðåïàðàòà [29].

27
Australian approval for infliximab biosimilar. Available from: https:// goo.gl/qzMJaT.
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    Îñíîâàíèåì ñòàëî îòñóòñòâèå äîêàçàòåëüñòâ êëèíè÷åñêîé ýêâèâàëåíòíîñòè ïðè ñóùåñòâîâàíèè ðàçëè÷èé â ìåõàíèçìå ðåàëèçàöèè êëèíè÷åñêîãî ýôôåêòà ïðè ïðèìåíåíèè èíôëèêñèìàáà ïðè âîñïàëèòåëüíûõ çàáîëåâàíèÿõ êèøå÷íèêà è âîñïàëèòåëüíûõ çàáîëåâàíèÿõ ñóñòàâîâ è ïñîðèàçå [26].  Àâñòðàëèè ïðåïàðàò çàðåãèñòðèðîâàí íà îñíîâå äàííûõ ÅÌÀ ïî âñåì ïîêàçàíèÿì, èìåþùèìñÿ ó Ðåìèêåéäà
    Exact
    [27]
    Suffix
    .  òî æå âðåìÿ â ßïîíèè âêëþ÷åíû â ïîêàçàíèÿ òîëüêî ÐÀ, ÁÊ è ßÊ [28]. Âàæíî îòìåòèòü, ÷òî â àïðåëå 2016 ãîäà FDA çàðåãèñòðèðîâàëî ýòîò áèîàíàëîã, ïîäàííûé äëÿ ðàññìîòðåíèÿ â FDA â 2014 ãîäó (ïîä òîðãîâûì íàèìåíîâàíèåì Èíôëåêòðà), ýêñòðàïîëèðóÿ âñå ïîêàçàíèÿ ðåôåðåíòíîãî ïðåïàðàòà [29].

28
Wang J, Chow S-C. On the regulatory approval pathway of biosimilar products. Pharmaceuticals 2012; 5(4): 353–68.
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  1. In-text reference with the coordinate start=17816
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    êëèíè÷åñêîé ýêâèâàëåíòíîñòè ïðè ñóùåñòâîâàíèè ðàçëè÷èé â ìåõàíèçìå ðåàëèçàöèè êëèíè÷åñêîãî ýôôåêòà ïðè ïðèìåíåíèè èíôëèêñèìàáà ïðè âîñïàëèòåëüíûõ çàáîëåâàíèÿõ êèøå÷íèêà è âîñïàëèòåëüíûõ çàáîëåâàíèÿõ ñóñòàâîâ è ïñîðèàçå [26].  Àâñòðàëèè ïðåïàðàò çàðåãèñòðèðîâàí íà îñíîâå äàííûõ ÅÌÀ ïî âñåì ïîêàçàíèÿì, èìåþùèìñÿ ó Ðåìèêåéäà [27].  òî æå âðåìÿ â ßïîíèè âêëþ÷åíû â ïîêàçàíèÿ òîëüêî ÐÀ, ÁÊ è ßÊ
    Exact
    [28]
    Suffix
    . Âàæíî îòìåòèòü, ÷òî â àïðåëå 2016 ãîäà FDA çàðåãèñòðèðîâàëî ýòîò áèîàíàëîã, ïîäàííûé äëÿ ðàññìîòðåíèÿ â FDA â 2014 ãîäó (ïîä òîðãîâûì íàèìåíîâàíèåì Èíôëåêòðà), ýêñòðàïîëèðóÿ âñå ïîêàçàíèÿ ðåôåðåíòíîãî ïðåïàðàòà [29].

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    ÃÐÀÍÈÖÛ ÝÊÂÈÂÀËÅÍÒÍÎÑÒÈ ÁÈÎÀÍÀËÎÃÀ ÈËÈ ÍÅ ÌÅÍÜØÅÉ ÝÔÔÅÊÒÈÂÍÎÑÒÈ Îäíîé èç âàæíûõ ïðîáëåì ÿâëÿåòñÿ âåëè÷èíà ãðàíèöû ïðèçíàíèÿ ýêâèâàëåíòíîñòè áèîàíàëîãà ðåôåðåíòíîìó ïðåïàðàòó.  îïðåäåëåííîé ñèòóàöèè âîçìîæíî ïðèìåíåíèå äèçàéíà íå ìåíüøåé ýôôåêòèâíîñòè, íî ýòî ñêîðåå èñêëþ÷åíèå, ÷åì ïðàâèëî
    Exact
    [28]
    Suffix
    . Îáîñíîâàíèå ãðàíèö ýêâèâàëåíòíîñòè äîëæíî ñòðîèòüñÿ êàê íà êëèíè÷åñêèõ, òàê è íà ñòàòèñòè÷åñêèõ ïðåäïîñûëêàõ [35, 36]. FDA è EMA ðåêîìåíäóþò ïðîâåäåíèå èññëåäîâàíèÿ ýêâèâàëåíòíîñòè â ðàìêàõ çàðàíåå îáîñíîâàííûõ ãðàíèö â ñëó÷àå íåîáõîäèìîñòè äîêàçàòåëüñòâà ñîïîñòàâèìîé êëèíè÷åñêîé ýôôåêòèâíîñòè áèîàíàëîãà è «îðèãèíàëüíîãî »ïðåïàðàòà [28].

  3. In-text reference with the coordinate start=20395
    Prefix
    FDA è EMA ðåêîìåíäóþò ïðîâåäåíèå èññëåäîâàíèÿ ýêâèâàëåíòíîñòè â ðàìêàõ çàðàíåå îáîñíîâàííûõ ãðàíèö â ñëó÷àå íåîáõîäèìîñòè äîêàçàòåëüñòâà ñîïîñòàâèìîé êëèíè÷åñêîé ýôôåêòèâíîñòè áèîàíàëîãà è «îðèãèíàëüíîãî »ïðåïàðàòà
    Exact
    [28]
    Suffix
    . Ðåãóëÿòîðíûå òðåáîâàíèÿ Àâñòðàëèè è Êàíàäû òàêæå óêàçûâàþò íà íåîáõîäèìîñòü ïðåäïî÷òåíèÿ äèçàéíà ýêâèâàëåíòíîñòè, îäíàêî äîïóñêàþò âîçìîæíîñòü ïðîâåäåíèÿ èññëåäîâàíèÿ íå ìåíüøåé ýôôåêòèâíîñòè â ñëó÷àå Òàáëèöà 5 ÈÑÑËÅÄÎÂÀÍÈß ÊËÈÍÈ×ÅÑÊÎÉ ÝÔÔÅÊÒÈÂÍÎÑÒÈ ÁÈÎÀÍÀËÎÃΠÀÄÀËÈÌÓÌÀÁÀ  ÌÈÐÅ [23] Íàèìåíîâàíèå êîìïàíèè Íàçâàíèå ïðåïàðàòàÏîêàçàíèå Íà÷àëî èññëåäîâàíèÿ×èñëî ïàöèåíòîâ Íîìåð èññëåäîâàíèÿ (NCT

29
Press relies, April 5, 2016. FDA approvesInflectra, a biosimilar to Remicade. Available from: https:// goo.gl/cfrX4X.
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    Âàæíî îòìåòèòü, ÷òî â àïðåëå 2016 ãîäà FDA çàðåãèñòðèðîâàëî ýòîò áèîàíàëîã, ïîäàííûé äëÿ ðàññìîòðåíèÿ â FDA â 2014 ãîäó (ïîä òîðãîâûì íàèìåíîâàíèåì Èíôëåêòðà), ýêñòðàïîëèðóÿ âñå ïîêàçàíèÿ ðåôåðåíòíîãî ïðåïàðàòà
    Exact
    [29]
    Suffix
    . Ïðåïàðàò áûë çàðåãèñòðèðîâàí êàê áèîàíàëîã, à íå êàê âçàèìîçàìåíÿåìûé ïðåïàðàò. Ïðîöåäóðà ïðîâîäèëàñü â ñîîòâåòñòâèè ñ BPCIA [30]. Âåñüìà ïîêàçàòåëüíî, ÷òî â ñòðàíàõ ñ ðàçâèòîé ñèñòåìîé çäðàâîîõðàíåíèÿ, ïðîôåññèîíàëüíûìè ñîþçàìè è íàó÷íûìè îáùåñòâàìè ñóùåñòâóåò íåîäíîçíà÷íîå îòíîøåíèå ê îáîñíîâàííîñòè ýêñòðàïîëÿöèè ïîêàçàíèé áèîàíàëîãà, â ÷àñòíîñòè äëÿ èíôëèêñèìàáà, äàæå åñëè ïðîäóêò îäîáðåí

30
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    Âàæíî îòìåòèòü, ÷òî â àïðåëå 2016 ãîäà FDA çàðåãèñòðèðîâàëî ýòîò áèîàíàëîã, ïîäàííûé äëÿ ðàññìîòðåíèÿ â FDA â 2014 ãîäó (ïîä òîðãîâûì íàèìåíîâàíèåì Èíôëåêòðà), ýêñòðàïîëèðóÿ âñå ïîêàçàíèÿ ðåôåðåíòíîãî ïðåïàðàòà [29]. Ïðåïàðàò áûë çàðåãèñòðèðîâàí êàê áèîàíàëîã, à íå êàê âçàèìîçàìåíÿåìûé ïðåïàðàò. Ïðîöåäóðà ïðîâîäèëàñü â ñîîòâåòñòâèè ñ BPCIA
    Exact
    [30]
    Suffix
    . Âåñüìà ïîêàçàòåëüíî, ÷òî â ñòðàíàõ ñ ðàçâèòîé ñèñòåìîé çäðàâîîõðàíåíèÿ, ïðîôåññèîíàëüíûìè ñîþçàìè è íàó÷íûìè îáùåñòâàìè ñóùåñòâóåò íåîäíîçíà÷íîå îòíîøåíèå ê îáîñíîâàííîñòè ýêñòðàïîëÿöèè ïîêàçàíèé áèîàíàëîãà, â ÷àñòíîñòè äëÿ èíôëèêñèìàáà, äàæå åñëè ïðîäóêò îäîáðåí ðåãóëÿòîðíûì îðãàíîì.

31
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    Íàïðèìåð, Åâðîïåéñêîå îáùåñòâî ïî èçó÷åíèþ áîëåçíè Êðîíà è ÿçâåííîãî êîëèòà (European Crohn’s and Colitis Organisation, ÅÑÑÎ) êðèòèêóåò ðåøåíèå ÅÌÀ î âêëþ÷åíèè â ïîêàçàíèÿ ïðåïàðàòà Ðåìñèìà âîñïàëèòåëüíûõ çàáîëåâàíèé êèøå÷íèêà. Ñîòðóäíèêè ÅÑÑÎ ïîëàãàþò, ÷òî äëÿ âêëþ÷åíèÿ ýòèõ ïîêàçàíèé íåîáõîäèìî ïîëó÷åíèå îäíîçíà÷íûõ ðåçóëüòàòîâ êëèíè÷åñêèõ èññëåäîâàíèé è çàêëþ÷åíèå îðãàíîâ ôàðìàêîíàäçîðà
    Exact
    [31]
    Suffix
    .  òî æå âðåìÿ â Åâðîïå ïðåäëàãàþò ïðîôåññèîíàëüíîìó ñîîáùåñòâó áîëåå øèðîêî îáñóæäàòü ïðîãðàììû ðàçðàáîòêè áèîàíàëîãîâ äî ýòàïà ðåøåíèÿ ðåãóëÿòîðíîãî îðãàíà [32]. Àíàëîãè÷íàÿ ïîçèöèÿ Áðàçèëüñêîãî íàó÷íîãî îáùåñòâà ïî èçó÷åíèþ âîñïàëèòåëüíûõ çàáîëåâàíèé êèøå÷íèêà (Brazilian Study Group of Inflammatory Bowel Diseases, GEDIIB) çàêëþ÷àåòñÿ â íåñîãëàñèè ñ ðåøåíèåì î ðåãèñòðàöèè â Áðàçèëèè ïðåïàðàòà ñ

32
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    Ñîòðóäíèêè ÅÑÑÎ ïîëàãàþò, ÷òî äëÿ âêëþ÷åíèÿ ýòèõ ïîêàçàíèé íåîáõîäèìî ïîëó÷åíèå îäíîçíà÷íûõ ðåçóëüòàòîâ êëèíè÷åñêèõ èññëåäîâàíèé è çàêëþ÷åíèå îðãàíîâ ôàðìàêîíàäçîðà [31].  òî æå âðåìÿ â Åâðîïå ïðåäëàãàþò ïðîôåññèîíàëüíîìó ñîîáùåñòâó áîëåå øèðîêî îáñóæäàòü ïðîãðàììû ðàçðàáîòêè áèîàíàëîãîâ äî ýòàïà ðåøåíèÿ ðåãóëÿòîðíîãî îðãàíà
    Exact
    [32]
    Suffix
    . Àíàëîãè÷íàÿ ïîçèöèÿ Áðàçèëüñêîãî íàó÷íîãî îáùåñòâà ïî èçó÷åíèþ âîñïàëèòåëüíûõ çàáîëåâàíèé êèøå÷íèêà (Brazilian Study Group of Inflammatory Bowel Diseases, GEDIIB) çàêëþ÷àåòñÿ â íåñîãëàñèè ñ ðåøåíèåì î ðåãèñòðàöèè â Áðàçèëèè ïðåïàðàòà ñ âêëþ÷åíèåì âñåãî ñïåêòðà ïîêàçàíèé áèîàíàëîãà èíôëèêñèìàáà, êîòîðîå áûëî ïðèíÿòî ðåãóëÿòîðíûì îðãàíîì — Íàöèîíàëüíûì àãåíòñòâîì íàáëþäåíèÿ çà çäîðîâüåì (Agencia N

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    îáùåñòâà ïî èçó÷åíèþ âîñïàëèòåëüíûõ çàáîëåâàíèé êèøå÷íèêà (Brazilian Study Group of Inflammatory Bowel Diseases, GEDIIB) çàêëþ÷àåòñÿ â íåñîãëàñèè ñ ðåøåíèåì î ðåãèñòðàöèè â Áðàçèëèè ïðåïàðàòà ñ âêëþ÷åíèåì âñåãî ñïåêòðà ïîêàçàíèé áèîàíàëîãà èíôëèêñèìàáà, êîòîðîå áûëî ïðèíÿòî ðåãóëÿòîðíûì îðãàíîì — Íàöèîíàëüíûì àãåíòñòâîì íàáëþäåíèÿ çà çäîðîâüåì (Agencia Nacional de Vigilancia Sanitaria, ANVISA)
    Exact
    [33]
    Suffix
    .  êà÷åñòâå ïîäòâåðæäåíèÿ ïîäîáíîé ïîçèöèè ïðèâîäÿòñÿ äàííûå èññëåäîâàíèÿ ïðåïàðàòà, ïðîâåäåííîãî â Èðëàíäèè, êîòîðîå ïðîäåìîíñòðèðîâàëî ïîâûøåíèå ÷àñòîòû íåîáõîäèìîñòè ïðèìåíåíèÿ ãëþêîêîðòèêîñòåðîèäîâ è õèðóðãè÷åñêîé ïîìîùè ó áîëüíûõ, ïîëó÷àâøèõ áèîàíàëîã èíôëèêñèìàáà â ñðàâíåíèè ñ ðåôåðåíòíûì ïðåïàðàòîì [34].

34
Murphy C, Sugrue K, Mohamad G, McCarthy J, Buckley M. Biosimilar but not the same. J Crohn’s Colitis 2015; 9(Suppl 1): S331–2.
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     êà÷åñòâå ïîäòâåðæäåíèÿ ïîäîáíîé ïîçèöèè ïðèâîäÿòñÿ äàííûå èññëåäîâàíèÿ ïðåïàðàòà, ïðîâåäåííîãî â Èðëàíäèè, êîòîðîå ïðîäåìîíñòðèðîâàëî ïîâûøåíèå ÷àñòîòû íåîáõîäèìîñòè ïðèìåíåíèÿ ãëþêîêîðòèêîñòåðîèäîâ è õèðóðãè÷åñêîé ïîìîùè ó áîëüíûõ, ïîëó÷àâøèõ áèîàíàëîã èíôëèêñèìàáà â ñðàâíåíèè ñ ðåôåðåíòíûì ïðåïàðàòîì
    Exact
    [34]
    Suffix
    . ÃÐÀÍÈÖÛ ÝÊÂÈÂÀËÅÍÒÍÎÑÒÈ ÁÈÎÀÍÀËÎÃÀ ÈËÈ ÍÅ ÌÅÍÜØÅÉ ÝÔÔÅÊÒÈÂÍÎÑÒÈ Îäíîé èç âàæíûõ ïðîáëåì ÿâëÿåòñÿ âåëè÷èíà ãðàíèöû ïðèçíàíèÿ ýêâèâàëåíòíîñòè áèîàíàëîãà ðåôåðåíòíîìó ïðåïàðàòó.  îïðåäåëåííîé ñèòóàöèè âîçìîæíî ïðèìåíåíèå äèçàéíà íå ìåíüøåé ýôôåêòèâíîñòè, íî ýòî ñêîðåå èñêëþ÷åíèå, ÷åì ïðàâèëî [28].

35
U. S. Food and Drug Administration. Draft guidance for industry. Non-inferiorityclinicaltrials.2016.Availablefrom: https:// goo.gl/csfW1o.
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     îïðåäåëåííîé ñèòóàöèè âîçìîæíî ïðèìåíåíèå äèçàéíà íå ìåíüøåé ýôôåêòèâíîñòè, íî ýòî ñêîðåå èñêëþ÷åíèå, ÷åì ïðàâèëî [28]. Îáîñíîâàíèå ãðàíèö ýêâèâàëåíòíîñòè äîëæíî ñòðîèòüñÿ êàê íà êëèíè÷åñêèõ, òàê è íà ñòàòèñòè÷åñêèõ ïðåäïîñûëêàõ
    Exact
    [35, 36]
    Suffix
    . FDA è EMA ðåêîìåíäóþò ïðîâåäåíèå èññëåäîâàíèÿ ýêâèâàëåíòíîñòè â ðàìêàõ çàðàíåå îáîñíîâàííûõ ãðàíèö â ñëó÷àå íåîáõîäèìîñòè äîêàçàòåëüñòâà ñîïîñòàâèìîé êëèíè÷åñêîé ýôôåêòèâíîñòè áèîàíàëîãà è «îðèãèíàëüíîãî »ïðåïàðàòà [28].

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European Medicines Agency. Guideline on the choice of the non-inferiority margin. 2005. Available from: https:// goo.gl/nc39WD.
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     îïðåäåëåííîé ñèòóàöèè âîçìîæíî ïðèìåíåíèå äèçàéíà íå ìåíüøåé ýôôåêòèâíîñòè, íî ýòî ñêîðåå èñêëþ÷åíèå, ÷åì ïðàâèëî [28]. Îáîñíîâàíèå ãðàíèö ýêâèâàëåíòíîñòè äîëæíî ñòðîèòüñÿ êàê íà êëèíè÷åñêèõ, òàê è íà ñòàòèñòè÷åñêèõ ïðåäïîñûëêàõ
    Exact
    [35, 36]
    Suffix
    . FDA è EMA ðåêîìåíäóþò ïðîâåäåíèå èññëåäîâàíèÿ ýêâèâàëåíòíîñòè â ðàìêàõ çàðàíåå îáîñíîâàííûõ ãðàíèö â ñëó÷àå íåîáõîäèìîñòè äîêàçàòåëüñòâà ñîïîñòàâèìîé êëèíè÷åñêîé ýôôåêòèâíîñòè áèîàíàëîãà è «îðèãèíàëüíîãî »ïðåïàðàòà [28].

37
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    -40 Fuji Film Kyowa Kirin Biologics FKB327ÐÀ2014600NCT02260791 2014-000109-11 PfizerPF-06410293ÐÀ2014560NCT02480153 2014-000352-29 Samsung BioepisSB5ÐÀ2014490NCT02167139 2013-005013-13 Sandoz/NovartisGP2017Ïñîðèàç2013448NCT02016105 2013-000747-11 Biocon, Mylan IncMYL-1401AÏñîðèàç20152942014-003420-46 Coherus biosciencesCHS-1420Ïñîðèàç2015500NCT02489227 2015-000632-15 ïðèåìëåìîãî îáîñíîâàíèÿ
    Exact
    [37]
    Suffix
    . Ïðè ýòîì ñòàòèñòè÷åñêèå ïîñòðîåíèÿ èñïîëüçóþò äàííûå ïëàöåáî-êîíòðîëèðóåìûõ èññëåäîâàíèé ðåôåðåíòíîãî ïðåïàðàòà, à òàêæå äàííûå èññëåäîâàíèé â ñðàâíåíèè ñî ñòàíäàðòíîé òåðàïèåé. Íåîáõîäèìî ó÷èòûâàòü ìàêñèìàëüíóþ ñîâîêóïíîñòü äàííûõ, òàê êàê èçìåí÷èâîñòü ýôôåêòà íå ìîæåò áûòü ó÷òåíà ïðè îöåíêå ðåçóëüòàòîâ åäèíñòâåííîãî èññëåäîâàíèÿ.

38
Kolesnikova EYu. Pharmacoepidemiological studies of adverse reactions of developed drugs. Safety and Risk of Pharmacotherapy 2014; 3(4): 27–30 (in Russian).
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    ÷òåíèþ äèçàéíà íå ìåíüøåé ýôôåêòèâíîñòè, îñíîâàííîìó íà ìåíüøåé ÷èñëåííîñòè, ïðåïÿòñòâóåò íåâîçìîæíîñòü èñêëþ÷åíèÿ áîëåå âûñîêîé àêòèâíîñòè áèîàíàëîãà, ÷òî ìîæåò ïðèâîäèòü ê áîëåå âûñîêîé ÷àñòîòå íåæåëàòåëüíûõ ÿâëåíèé è áèîàíàëîã íå ìîæåò áûòü ïðèçíàí òàêîâûì, à äîëæåí ðàññìàòðèâàòüñÿ êàê áèîëîãè÷åñêèé ïðåïàðàò ñ áîëåå âûñîêîé àêòèâíîñòüþ è íåîáõîäèìîñòüþ áîëåå òùàòåëüíîãî êëèíè÷åñêîãî èçó÷åíèÿ
    Exact
    [38]
    Suffix
    . Òàêèì îáðàçîì, äèçàéí ýêâèâàëåíòíîñòè ðåôåðåíòíîìó ïðåïàðàòó ÿâëÿåòñÿ áîëåå ñòðîãèì è îáîñíîâàííûì äëÿ äîêàçàòåëüñòâà áèîàíàëîãè÷íîñòè â óñëîâèÿõ êëèíè÷åñêîãî èçó÷åíèÿ. Ñëåäóåò îòìåòèòü, ÷òî âñå äåâÿòü èññëåäîâàíèé àäàëèìóìàáà, ïðåäñòàâëåííûõ â òàáëèöå 5, ïðîâåäåíû ïî äèçàéíó èññëåäîâàíèé ýêâèâàëåíòíîñòè.

39
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    ÅÌÀ îöåíèâàëî ÀÑ êàê ïðèåìëåìóþ è ÷óâñòâèòåëüíóþ ìîäåëü, òàê êàê áîëüíûå Òàáëèöà 4 ÎÖÅÍÊÀ ÏÅÐÂÈ×ÍÛÕ ÊÎÍÅ×ÍÛÕ ÒÎ×ÅÊ ÏËÀÖÅÁÎ ÊÎÍÒÐÎËÈÐÎÂÀÍÍÛÕ ÈÑÑËÅÄÎÂÀÍÈÉ ÀÄÀËÈÌÓÌÀÁÀ Ïîêàçàíèå Ñîïóòñòâóþùàÿ òåðàïèÿ Êîíå÷íàÿ òî÷êàÍåäåëÿ Îòâåò íà àäàëèìóìàá Îòâåò íà ïëàöåáî Ñòàíäàðòèçîâàííàÿ ïî ïëàöåáî ÷àñòîòà îòâåòà Èñòî÷íèê ÐÀÌÒACR2024651352
    Exact
    [39]
    Suffix
    ÍåòACR2026461927[40] MTACR2052592435[41] ÍåòACR2024533518[42] ÏñAÍåòACR2012581444[43] ÍåòACR2024571542 ÍåòACR2012391623[44] ÀÑÍåòASAS2012582137[45] ÁÊÍåòÊëèíè÷åñêèé îòâåò4593722[46] ÍåòÊëèíè÷åñêèé îòâåò4523418[47] ÍåòÊëèíè÷åñêèé îòâåò2654282648] ÍåòÊëèíè÷åñêèé îòâåò56431825 ßÊÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81899[49] ÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81798[50] Êëèíè÷åñêèé îòâåò52301812 ÏñîðèàçÍåòPASI751671764[51] Íå

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    Ðÿä ïðèíöèïèàëüíûõ ìîìåíòîâ, íåîáõîäèìûõ äëÿ ïëàíèðîâàíèÿ èññëåäîâàíèé ýêâèâàëåíòíîñòè, ñîäåðæèòñÿ â ðóêîâîäñòâàõ Ìåæäóíàðîäíîé êîíôåðåíöèè ïî ãàðìîíèçàöèè òåõíè÷åñêèõ òðåáîâàíèé ê ðåãèñòðàöèè ËÏ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH) E9 è E10
    Exact
    [39, 40]
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    , à òàêæå â «Ðóêîâîäñòâå ïî ïðîâåäåíèþ êëèíè÷åñêèõ èññëåäîâàíèé »[41]. Êàê óêàçàíî âûøå, ïåðâè÷íàÿ êîíå÷íàÿ òî÷êà èññëåäîâàíèÿ ýêâèâàëåíòíîñòè èëè íå ìåíüøåé ýôôåêòèâíîñòè äîëæíà áûòü îñíîâàíà íà ïåðâè÷íîé èëè âòîðè÷íîé êîíå÷íîé òî÷êå îñíîâíûõ èññëåäîâàíèé îðèãèíàòîðà.

40
ICH E9. Harmonised Tripartite Guideline: Statistical Principles for Clinical Trials E9. 5 Feb 1997. Available from: https:// goo.gl/AUtbxi.
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    ÅÌÀ îöåíèâàëî ÀÑ êàê ïðèåìëåìóþ è ÷óâñòâèòåëüíóþ ìîäåëü, òàê êàê áîëüíûå Òàáëèöà 4 ÎÖÅÍÊÀ ÏÅÐÂÈ×ÍÛÕ ÊÎÍÅ×ÍÛÕ ÒÎ×ÅÊ ÏËÀÖÅÁÎ ÊÎÍÒÐÎËÈÐÎÂÀÍÍÛÕ ÈÑÑËÅÄÎÂÀÍÈÉ ÀÄÀËÈÌÓÌÀÁÀ Ïîêàçàíèå Ñîïóòñòâóþùàÿ òåðàïèÿ Êîíå÷íàÿ òî÷êàÍåäåëÿ Îòâåò íà àäàëèìóìàá Îòâåò íà ïëàöåáî Ñòàíäàðòèçîâàííàÿ ïî ïëàöåáî ÷àñòîòà îòâåòà Èñòî÷íèê ÐÀÌÒACR2024651352[39] ÍåòACR2026461927
    Exact
    [40]
    Suffix
    MTACR2052592435[41] ÍåòACR2024533518[42] ÏñAÍåòACR2012581444[43] ÍåòACR2024571542 ÍåòACR2012391623[44] ÀÑÍåòASAS2012582137[45] ÁÊÍåòÊëèíè÷åñêèé îòâåò4593722[46] ÍåòÊëèíè÷åñêèé îòâåò4523418[47] ÍåòÊëèíè÷åñêèé îòâåò2654282648] ÍåòÊëèíè÷åñêèé îòâåò56431825 ßÊÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81899[49] ÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81798[50] Êëèíè÷åñêèé îòâåò52301812 ÏñîðèàçÍåòPASI751671764[51] ÍåòPASI7516801961[52] À

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    Ðÿä ïðèíöèïèàëüíûõ ìîìåíòîâ, íåîáõîäèìûõ äëÿ ïëàíèðîâàíèÿ èññëåäîâàíèé ýêâèâàëåíòíîñòè, ñîäåðæèòñÿ â ðóêîâîäñòâàõ Ìåæäóíàðîäíîé êîíôåðåíöèè ïî ãàðìîíèçàöèè òåõíè÷åñêèõ òðåáîâàíèé ê ðåãèñòðàöèè ËÏ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH) E9 è E10
    Exact
    [39, 40]
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    , à òàêæå â «Ðóêîâîäñòâå ïî ïðîâåäåíèþ êëèíè÷åñêèõ èññëåäîâàíèé »[41]. Êàê óêàçàíî âûøå, ïåðâè÷íàÿ êîíå÷íàÿ òî÷êà èññëåäîâàíèÿ ýêâèâàëåíòíîñòè èëè íå ìåíüøåé ýôôåêòèâíîñòè äîëæíà áûòü îñíîâàíà íà ïåðâè÷íîé èëè âòîðè÷íîé êîíå÷íîé òî÷êå îñíîâíûõ èññëåäîâàíèé îðèãèíàòîðà.

41
Guidance on clinical evaluation of medicines. Part 1. Moscow: Grif i K;2013 (in Russian).
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    ÅÌÀ îöåíèâàëî ÀÑ êàê ïðèåìëåìóþ è ÷óâñòâèòåëüíóþ ìîäåëü, òàê êàê áîëüíûå Òàáëèöà 4 ÎÖÅÍÊÀ ÏÅÐÂÈ×ÍÛÕ ÊÎÍÅ×ÍÛÕ ÒÎ×ÅÊ ÏËÀÖÅÁÎ ÊÎÍÒÐÎËÈÐÎÂÀÍÍÛÕ ÈÑÑËÅÄÎÂÀÍÈÉ ÀÄÀËÈÌÓÌÀÁÀ Ïîêàçàíèå Ñîïóòñòâóþùàÿ òåðàïèÿ Êîíå÷íàÿ òî÷êàÍåäåëÿ Îòâåò íà àäàëèìóìàá Îòâåò íà ïëàöåáî Ñòàíäàðòèçîâàííàÿ ïî ïëàöåáî ÷àñòîòà îòâåòà Èñòî÷íèê ÐÀÌÒACR2024651352[39] ÍåòACR2026461927[40] MTACR2052592435
    Exact
    [41]
    Suffix
    ÍåòACR2024533518[42] ÏñAÍåòACR2012581444[43] ÍåòACR2024571542 ÍåòACR2012391623[44] ÀÑÍåòASAS2012582137[45] ÁÊÍåòÊëèíè÷åñêèé îòâåò4593722[46] ÍåòÊëèíè÷åñêèé îòâåò4523418[47] ÍåòÊëèíè÷åñêèé îòâåò2654282648] ÍåòÊëèíè÷åñêèé îòâåò56431825 ßÊÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81899[49] ÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81798[50] Êëèíè÷åñêèé îòâåò52301812 ÏñîðèàçÍåòPASI751671764[51] ÍåòPASI7516801961[52] ÀÑ ïðåäñòàâëÿþò ñîáîé

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    äëÿ ïëàíèðîâàíèÿ èññëåäîâàíèé ýêâèâàëåíòíîñòè, ñîäåðæèòñÿ â ðóêîâîäñòâàõ Ìåæäóíàðîäíîé êîíôåðåíöèè ïî ãàðìîíèçàöèè òåõíè÷åñêèõ òðåáîâàíèé ê ðåãèñòðàöèè ËÏ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH) E9 è E10 [39, 40], à òàêæå â «Ðóêîâîäñòâå ïî ïðîâåäåíèþ êëèíè÷åñêèõ èññëåäîâàíèé »
    Exact
    [41]
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    . Êàê óêàçàíî âûøå, ïåðâè÷íàÿ êîíå÷íàÿ òî÷êà èññëåäîâàíèÿ ýêâèâàëåíòíîñòè èëè íå ìåíüøåé ýôôåêòèâíîñòè äîëæíà áûòü îñíîâàíà íà ïåðâè÷íîé èëè âòîðè÷íîé êîíå÷íîé òî÷êå îñíîâíûõ èññëåäîâàíèé îðèãèíàòîðà.

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Kay J, Smolen JS. Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis. 2013; 72(10): 1589–93.
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    ÅÌÀ îöåíèâàëî ÀÑ êàê ïðèåìëåìóþ è ÷óâñòâèòåëüíóþ ìîäåëü, òàê êàê áîëüíûå Òàáëèöà 4 ÎÖÅÍÊÀ ÏÅÐÂÈ×ÍÛÕ ÊÎÍÅ×ÍÛÕ ÒÎ×ÅÊ ÏËÀÖÅÁÎ ÊÎÍÒÐÎËÈÐÎÂÀÍÍÛÕ ÈÑÑËÅÄÎÂÀÍÈÉ ÀÄÀËÈÌÓÌÀÁÀ Ïîêàçàíèå Ñîïóòñòâóþùàÿ òåðàïèÿ Êîíå÷íàÿ òî÷êàÍåäåëÿ Îòâåò íà àäàëèìóìàá Îòâåò íà ïëàöåáî Ñòàíäàðòèçîâàííàÿ ïî ïëàöåáî ÷àñòîòà îòâåòà Èñòî÷íèê ÐÀÌÒACR2024651352[39] ÍåòACR2026461927[40] MTACR2052592435[41] ÍåòACR2024533518
    Exact
    [42]
    Suffix
    ÏñAÍåòACR2012581444[43] ÍåòACR2024571542 ÍåòACR2012391623[44] ÀÑÍåòASAS2012582137[45] ÁÊÍåòÊëèíè÷åñêèé îòâåò4593722[46] ÍåòÊëèíè÷åñêèé îòâåò4523418[47] ÍåòÊëèíè÷åñêèé îòâåò2654282648] ÍåòÊëèíè÷åñêèé îòâåò56431825 ßÊÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81899[49] ÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81798[50] Êëèíè÷åñêèé îòâåò52301812 ÏñîðèàçÍåòPASI751671764[51] ÍåòPASI7516801961[52] ÀÑ ïðåäñòàâëÿþò ñîáîé â îñíîâíîì ìîëîäóþ ï

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    Âûáîð âåëè÷èíû ñíèæåíèÿ ïîëó÷åííîãîçíà÷åíèÿäëÿãðàíèöûïðèçíàíèÿ ýêâèâàëåíòíîñòè çàâèñèò îò ñòåïåíè òî÷íîñòè èññëåäîâàíèÿ è ÷àñòî ðåàëèçóåòñÿ äåëåíèåì íà 2 (èñïîëüçîâàíèå 50 %) çíà÷åíèÿ íèæíåé ãðàíèöû äîâåðèòåëüíîãî èíòåðâàëà, ðàçëè÷èÿ ïðåïàðàòà ñðàâíåíèÿ è ïëàöåáî
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    [42]
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    . Êëèíè÷åñêàÿ çíà÷èìîñòü ãðàíèö ýêâèâàëåíòíîñòè äîëæíà áûòü ïîäðîáíî îáñóæäåíà â êîíòåêñòå ñîâîêóïíîñòè äàííûõ ïî ñðàâíåíèþ áèîàíàëîãà ñ ðåôåðåíòíûì ïðåïàðàòîì. Íàïðèìåð, äëÿ áèîàíàëîãà èíôëèêñèìàáà (Ðåìñèìà/Èíôëåêòðà/Ôëàììýãèñ) áûëà îáîñíîâàíà ðàçðàáîò÷èêîì ãðàíèöà 15 % äëÿ îöåíêè îòâåòà ïî ACR20 íà 30-é íåäåëå òåðàïèè [9, 16].

43
Maini R, St Clair EW, Breedveld F, Furst D, Kalden J. Weisman M, et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet 1999; 354(9194): 1932–9.
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    ÀÑ êàê ïðèåìëåìóþ è ÷óâñòâèòåëüíóþ ìîäåëü, òàê êàê áîëüíûå Òàáëèöà 4 ÎÖÅÍÊÀ ÏÅÐÂÈ×ÍÛÕ ÊÎÍÅ×ÍÛÕ ÒÎ×ÅÊ ÏËÀÖÅÁÎ ÊÎÍÒÐÎËÈÐÎÂÀÍÍÛÕ ÈÑÑËÅÄÎÂÀÍÈÉ ÀÄÀËÈÌÓÌÀÁÀ Ïîêàçàíèå Ñîïóòñòâóþùàÿ òåðàïèÿ Êîíå÷íàÿ òî÷êàÍåäåëÿ Îòâåò íà àäàëèìóìàá Îòâåò íà ïëàöåáî Ñòàíäàðòèçîâàííàÿ ïî ïëàöåáî ÷àñòîòà îòâåòà Èñòî÷íèê ÐÀÌÒACR2024651352[39] ÍåòACR2026461927[40] MTACR2052592435[41] ÍåòACR2024533518[42] ÏñAÍåòACR2012581444
    Exact
    [43]
    Suffix
    ÍåòACR2024571542 ÍåòACR2012391623[44] ÀÑÍåòASAS2012582137[45] ÁÊÍåòÊëèíè÷åñêèé îòâåò4593722[46] ÍåòÊëèíè÷åñêèé îòâåò4523418[47] ÍåòÊëèíè÷åñêèé îòâåò2654282648] ÍåòÊëèíè÷åñêèé îòâåò56431825 ßÊÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81899[49] ÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81798[50] Êëèíè÷åñêèé îòâåò52301812 ÏñîðèàçÍåòPASI751671764[51] ÍåòPASI7516801961[52] ÀÑ ïðåäñòàâëÿþò ñîáîé â îñíîâíîì ìîëîäóþ ïîïóëÿöèþ ìóæ÷èí áåç ñîïó

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    Íàïðèìåð, äëÿ áèîàíàëîãà èíôëèêñèìàáà (Ðåìñèìà/Èíôëåêòðà/Ôëàììýãèñ) áûëà îáîñíîâàíà ðàçðàáîò÷èêîì ãðàíèöà 15 % äëÿ îöåíêè îòâåòà ïî ACR20 íà 30-é íåäåëå òåðàïèè [9, 16]. Ýòà ãðàíèöà áûëà ñîãëàñîâàíà ñ ÅÌÀ è îñíîâàíà íà ðåçóëüòàòàõ ìàòåìàòè÷åñêîãî àíàëèçà, îñíîâó êîòîðîãî ñîñòàâèëî èññëåäîâàíèå ATTRACT
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    . Îíà ñîñòàâëÿëà îêîëî 50 % îò ðàçëè÷èÿ òî÷å÷íûõ çíà÷åíèé ÷àñòîò ãðóïïû òåðàïèè èíôëèêñèìàáîì â ñîîòâåòñòâóþùåì ðåæèìå è ïëàöåáî. Ïðè ýòîì íèæíÿÿ ãðàíèöà 95 % äîâåðèòåëüíîãî èíòåðâàëà (ÄÈ) ðàçíèöû ÷àñòîò ñîîòâåòñòâóåò ïðèáëèçèòåëüíî 17 %.

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Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017; 76(1): 58–64.
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    , òàê êàê áîëüíûå Òàáëèöà 4 ÎÖÅÍÊÀ ÏÅÐÂÈ×ÍÛÕ ÊÎÍÅ×ÍÛÕ ÒÎ×ÅÊ ÏËÀÖÅÁÎ ÊÎÍÒÐÎËÈÐÎÂÀÍÍÛÕ ÈÑÑËÅÄÎÂÀÍÈÉ ÀÄÀËÈÌÓÌÀÁÀ Ïîêàçàíèå Ñîïóòñòâóþùàÿ òåðàïèÿ Êîíå÷íàÿ òî÷êàÍåäåëÿ Îòâåò íà àäàëèìóìàá Îòâåò íà ïëàöåáî Ñòàíäàðòèçîâàííàÿ ïî ïëàöåáî ÷àñòîòà îòâåòà Èñòî÷íèê ÐÀÌÒACR2024651352[39] ÍåòACR2026461927[40] MTACR2052592435[41] ÍåòACR2024533518[42] ÏñAÍåòACR2012581444[43] ÍåòACR2024571542 ÍåòACR2012391623
    Exact
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    ÀÑÍåòASAS2012582137[45] ÁÊÍåòÊëèíè÷åñêèé îòâåò4593722[46] ÍåòÊëèíè÷åñêèé îòâåò4523418[47] ÍåòÊëèíè÷åñêèé îòâåò2654282648] ÍåòÊëèíè÷åñêèé îòâåò56431825 ßÊÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81899[49] ÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81798[50] Êëèíè÷åñêèé îòâåò52301812 ÏñîðèàçÍåòPASI751671764[51] ÍåòPASI7516801961[52] ÀÑ ïðåäñòàâëÿþò ñîáîé â îñíîâíîì ìîëîäóþ ïîïóëÿöèþ ìóæ÷èí áåç ñîïóòñòâóþùåé ïàòîëîãèè, íå ïîëó÷àþùóþ èìì

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    Ïîêàçàòåëüíî, ÷òî ãðàíèöà â 15 % áûëà ïðèíÿòà ÅÌÀ (Êîìèòåòîì ïî ëåêàðñòâåííûì ñðåäñòâàì äëÿ ïðèìåíåíèÿ ó ÷åëîâåêà — Committee for Medicinal Products for Human Use, CHMP) ïðè ó÷åòå âñåé ñîâîêóïíîñòè ïðåäûäóùèõ èññëåäîâàíèé, ïîäòâåðæäàþùèõ áèîàíàëîãè÷íîñòü [9, 16]. Òàêàÿ æå ãðàíèöà ýêâèâàëåíòíîñòè (15 %) áûëà èñïîëüçîâàíà â èññëåäîâàíèè III ôàçû áèîàíàëîãà èíôëèêñèìàáà êîìïàíèè «Samsung Bioepis »
    Exact
    [44]
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    è â èññëåäîâàíèè áèîàíàëîãà ýòàíåðöåïòà ýòîé æå êîìïàíèè [45]. ×èñëåííîñòü äîáðîâîëüöåâ, ó÷àñòâóþùèõ â èññëåäîâàíèè, ïîìèìî ïëàíèðóåìîé ñòàòèñòè÷åñêîé çíà÷èìîñòè, ìîùíîñòè è ÷àñòîòû âûáûâàíèÿ íàïðÿìóþ çàâèñèò îò ãðàíèöû ýêâèâàëåíòíîñòè.

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Emery P, Vencovsky, J, Sylwestrzak A, Leszczynski P, Porawska W, Baranauskaite A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017; 76(1): 51–7.
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    4 ÎÖÅÍÊÀ ÏÅÐÂÈ×ÍÛÕ ÊÎÍÅ×ÍÛÕ ÒÎ×ÅÊ ÏËÀÖÅÁÎ ÊÎÍÒÐÎËÈÐÎÂÀÍÍÛÕ ÈÑÑËÅÄÎÂÀÍÈÉ ÀÄÀËÈÌÓÌÀÁÀ Ïîêàçàíèå Ñîïóòñòâóþùàÿ òåðàïèÿ Êîíå÷íàÿ òî÷êàÍåäåëÿ Îòâåò íà àäàëèìóìàá Îòâåò íà ïëàöåáî Ñòàíäàðòèçîâàííàÿ ïî ïëàöåáî ÷àñòîòà îòâåòà Èñòî÷íèê ÐÀÌÒACR2024651352[39] ÍåòACR2026461927[40] MTACR2052592435[41] ÍåòACR2024533518[42] ÏñAÍåòACR2012581444[43] ÍåòACR2024571542 ÍåòACR2012391623[44] ÀÑÍåòASAS2012582137
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    ÁÊÍåòÊëèíè÷åñêèé îòâåò4593722[46] ÍåòÊëèíè÷åñêèé îòâåò4523418[47] ÍåòÊëèíè÷åñêèé îòâåò2654282648] ÍåòÊëèíè÷åñêèé îòâåò56431825 ßÊÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81899[49] ÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81798[50] Êëèíè÷åñêèé îòâåò52301812 ÏñîðèàçÍåòPASI751671764[51] ÍåòPASI7516801961[52] ÀÑ ïðåäñòàâëÿþò ñîáîé â îñíîâíîì ìîëîäóþ ïîïóëÿöèþ ìóæ÷èí áåç ñîïóòñòâóþùåé ïàòîëîãèè, íå ïîëó÷àþùóþ èììóíîäåïðåññàíòû.

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    ñðåäñòâàì äëÿ ïðèìåíåíèÿ ó ÷åëîâåêà — Committee for Medicinal Products for Human Use, CHMP) ïðè ó÷åòå âñåé ñîâîêóïíîñòè ïðåäûäóùèõ èññëåäîâàíèé, ïîäòâåðæäàþùèõ áèîàíàëîãè÷íîñòü [9, 16]. Òàêàÿ æå ãðàíèöà ýêâèâàëåíòíîñòè (15 %) áûëà èñïîëüçîâàíà â èññëåäîâàíèè III ôàçû áèîàíàëîãà èíôëèêñèìàáà êîìïàíèè «Samsung Bioepis »[44] è â èññëåäîâàíèè áèîàíàëîãà ýòàíåðöåïòà ýòîé æå êîìïàíèè
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    . ×èñëåííîñòü äîáðîâîëüöåâ, ó÷àñòâóþùèõ â èññëåäîâàíèè, ïîìèìî ïëàíèðóåìîé ñòàòèñòè÷åñêîé çíà÷èìîñòè, ìîùíîñòè è ÷àñòîòû âûáûâàíèÿ íàïðÿìóþ çàâèñèò îò ãðàíèöû ýêâèâàëåíòíîñòè. Èññëåäîâàíèÿ èíôëèêñèìàáà èñõîäèëè èç 5 % äâóñòîðîííåé ñòàòèñòè÷åñêîé çíà÷èìîñòè, ìîùíîñòè 80 % è ÷àñòîòû âûáûâàíèÿ 20 %.

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Jani RH, Gupta R, Bhatia G, Rathi G, Ashok Kumar P, Sharma R, et al. A prospective, randomized, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis. Int J Rheum Dis. 2016; 19(11): 1157–68.
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    ÒÎ×ÅÊ ÏËÀÖÅÁÎ ÊÎÍÒÐÎËÈÐÎÂÀÍÍÛÕ ÈÑÑËÅÄÎÂÀÍÈÉ ÀÄÀËÈÌÓÌÀÁÀ Ïîêàçàíèå Ñîïóòñòâóþùàÿ òåðàïèÿ Êîíå÷íàÿ òî÷êàÍåäåëÿ Îòâåò íà àäàëèìóìàá Îòâåò íà ïëàöåáî Ñòàíäàðòèçîâàííàÿ ïî ïëàöåáî ÷àñòîòà îòâåòà Èñòî÷íèê ÐÀÌÒACR2024651352[39] ÍåòACR2026461927[40] MTACR2052592435[41] ÍåòACR2024533518[42] ÏñAÍåòACR2012581444[43] ÍåòACR2024571542 ÍåòACR2012391623[44] ÀÑÍåòASAS2012582137[45] ÁÊÍåòÊëèíè÷åñêèé îòâåò4593722
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    ÍåòÊëèíè÷åñêèé îòâåò4523418[47] ÍåòÊëèíè÷åñêèé îòâåò2654282648] ÍåòÊëèíè÷åñêèé îòâåò56431825 ßÊÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81899[49] ÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81798[50] Êëèíè÷åñêèé îòâåò52301812 ÏñîðèàçÍåòPASI751671764[51] ÍåòPASI7516801961[52] ÀÑ ïðåäñòàâëÿþò ñîáîé â îñíîâíîì ìîëîäóþ ïîïóëÿöèþ ìóæ÷èí áåç ñîïóòñòâóþùåé ïàòîëîãèè, íå ïîëó÷àþùóþ èììóíîäåïðåññàíòû.

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     ýòîé ñâÿçè ñëåäóåò îòìåòèòü èññëåäîâàíèå áèîàíàëîãà àäàëèìóìàáà — Åêñåìïòèÿ, êîòîðîå ïðîâåäåíî íà 120 ïàöèåíòàõ ñ ÐÀ ïðè ðàíäîìèçàöèè 60 ïàöèåíòîâ â ãðóïïó èçó÷àåìîãî ïðåïàðàòà, ÷òî áûëî îáîñíîâàíî ãðàíèöåé ïðèçíàíèÿ ýêâèâàëåíòíîñòè äëÿ ACR20 íà 12 íåäåëå — 28,5 %
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    .  äàííûé ìîìåíò íåÿñíî, áóäåò ëè êàêîé-ëèáî çàðóáåæíûé ðåãóëÿòîðíûé îðãàí òðåáîâàòü ïðîâåäåíèÿ èññëåäîâàíèÿ ñ áîëåå óçêèì äèàïàçîíîì ïðèçíàíèÿ ýêâèâàëåíòíîñòè, ÷òî ïðèâåäåò ê íåîáõîäèìîñòè óâåëè÷åíèÿ ÷èñëåííîñòè ïàöèåíòîâ.

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Kay J, Chopra A, Chandrashekara S, Wyand M. OP0012 A Phase 3, randomized, double-blind, active comparator study of the efficacy and safety of Bow015, a biosimilar Infliximab, in patients with active rheumatoid arthritis on stable Methotrexate doses. Ann Rheum Dis. 2014; 73(Suppl 2): 64.
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    ÈÑÑËÅÄÎÂÀÍÈÉ ÀÄÀËÈÌÓÌÀÁÀ Ïîêàçàíèå Ñîïóòñòâóþùàÿ òåðàïèÿ Êîíå÷íàÿ òî÷êàÍåäåëÿ Îòâåò íà àäàëèìóìàá Îòâåò íà ïëàöåáî Ñòàíäàðòèçîâàííàÿ ïî ïëàöåáî ÷àñòîòà îòâåòà Èñòî÷íèê ÐÀÌÒACR2024651352[39] ÍåòACR2026461927[40] MTACR2052592435[41] ÍåòACR2024533518[42] ÏñAÍåòACR2012581444[43] ÍåòACR2024571542 ÍåòACR2012391623[44] ÀÑÍåòASAS2012582137[45] ÁÊÍåòÊëèíè÷åñêèé îòâåò4593722[46] ÍåòÊëèíè÷åñêèé îòâåò4523418
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    ÍåòÊëèíè÷åñêèé îòâåò2654282648] ÍåòÊëèíè÷åñêèé îòâåò56431825 ßÊÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81899[49] ÍåòÊëèíè÷åñêàÿ ðåìèññèÿ81798[50] Êëèíè÷åñêèé îòâåò52301812 ÏñîðèàçÍåòPASI751671764[51] ÍåòPASI7516801961[52] ÀÑ ïðåäñòàâëÿþò ñîáîé â îñíîâíîì ìîëîäóþ ïîïóëÿöèþ ìóæ÷èí áåç ñîïóòñòâóþùåé ïàòîëîãèè, íå ïîëó÷àþùóþ èììóíîäåïðåññàíòû.

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    Ñõîäíûé ïðèíöèï ñ âûáîðîì øèðîêèõ ãðàíèö ïðèçíàíèÿ ýêâèâàëåíòíîñòè áûë ïðèìåíåí â èññëåäîâàíèè ïðåïàðàòà BOW015 — áèîàíàëîãà èíôëèêñèìàáà, 189 ïàöèåíòîâ ñ ÐÀ áûëè ðàíäîìèçèðîâàíû â ñîîòíîøåíèè 2:1, ïðè ãðàíèöå ïðèçíàíèÿ ýêâèâàëåíòíîñòè 23 %
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    .  íàñòîÿùåå âðåìÿ îòñóòñòâóþò ïðèåìëåìûå îòêðûòûå äàííûå äëÿ îáîñíîâàíèÿ ãðàíèöû ïðèçíàíèÿ ýêâèâàëåíòíîñòè èçó÷àåìîãî áèîàíàëîãà ïî ïîêàçàíèþ «ïñîðèàç». Ïðåäñòàâëåííàÿ â òàáëèöå 5 ÷èñëåííîñòü ó÷àñòíèêîâ èññëåäîâàíèé ýêâèâàëåíòíîñòè (îêîëî 300–650 áîëüíûõ) ñâèäåòåëüñòâóåò î áîëåå íèçêîé ÷èñëåííîñòè, ÷åì â èññëåäîâàíèÿõ íà ïàöèåíòàõ ñ ÐÀ.