The 16 references in paper A. Mironov N., V. Merkulov A., A. Lutseva I., O. Vaganova A., A. Bendryshev A., T. Efremova A., E. Kirichenko V., S. Shvets V., E. Ivanainen V., А. Миронов Н., В. Меркулов А., А. Лутцева И., О. Ваганова А., А. Бендрышев А., Т. Ефремова А., Е. Кириченко В., С. Швец Б., Е. Иванайнен Б. (2018) “Подходы к оценке биоаналогичности (биоподобия) биотехнологических лекарственных препаратов: вопросы качества // The approaches to the assessment of biosimilarity of biotechnological preparations: quality issues” / spz:neicon:vedomostincesmp:y:2015:i:1:p:4-10

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Summary of product characteristics. Inflectra. [cited 2014 Jan 23]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_ Product_Information/human/002778/WC500151489.pdf.
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Summary of product characteristics. Remsima. [cited 2014 Jan 23]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_ Product_Information/human/002778/WC500151489.pdf.
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Summary of product characteristics. Abasaglar. [cited 2014 Jan 23]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_ Product_Information/human/002835/WC500175381.pdf .
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Advisory committee briefing materials: available for public release. FDA Oncologic Drugs Advisory Committee Meeting ZARXIO® (filgrastim). January 7, R E F E R E N C E S Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, 8 Petrovsky Boulevard, Moscow, 127051, Russian Federation. Mironov AN. Director General. Doctor of Medical Sciences. Merkulov VA. First Deputy Director General. Doctor of Medical Sciences. Lutseva AI. Acting head of Test Center of Quality Expertise of Medicines. Candidate of Pharmaceutical Sciences. Vaganova OA. Head of Laboratory of biotech drugs of Test Center of Quality Expertise of Medicines. Candidate of Pharmaceutical Sciences. Bendryshev AA. Chief exper
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Guideline on similar biological medicinal products. URL: http://www.ema. europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/ WC500176768.pdf.
(check this in PDF content)
6
Guidance for Industry Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (draft guidance). [cited 2014 Jan 23]. Available from: http:// www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf.
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Guideline on similar biological medicinal products. [cited 2014 Jan 23]. Available from: http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf.
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Guideline on similar biological medicinal products containing Biotechnologyderived proteins as active substance: Non-clinical and clinical issues. [cited 2014 Jan 23]. Available from: http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf.
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Guideline on similar biological medicinal products containing Biotechnologyderived proteins as active substance: quality issues. [cited 2014 Jan 23]. Available from: http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf.
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Guidelines on evaluation of similar Biotherapeutic products (sbps). [cited 2014 Jan 23]. Available from: http:// www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf?ua=1.
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Guideline on similar biological medicinal products containing biotechnologyderived proteins as active substance: quality issues (revision 1)/ [cited 2014 Jan 23]. Available from: http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500167838.pdf.
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О внесении изменений в Федеральный закон «Об обращении лекарственных средств». Федеральный закон No 429 от 22 декабря 2014 г.
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13
Миронов А.Н., ред. Руководство по экспертизе лекарственных средств. Т. 4. М.: Полиграф Плюс; 2014.
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14
Guidance for Industry Q8(R2) Pharmaceutical Development. [cited 2014 Jan 23]. Available from: http://www.fda.gov/downloads/Drugs/Guidances/ ucm073507.pdf.
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Ваганова ОА, Ефремова ТА, Миронов АН. и др. Направления совершенствования лекарственных препаратов моноклональных антител. Ведомости Научного центра экспертизы средств медицинского применения 2014; 1: 32–39.
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Солдатов АА, Авдеева ЖИ, Алпатова НА и др. Проблемы регистрации биологических неоригинальных лекарственных препаратов. Биопрепараты 2014; 4(52): 24–36. 2015. [cited 2014 Jan 23]. Available from: http://www.fda.gov/. 5. Guideline on similar biological medicinal products. URL: http://www.ema.
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