The 8 references in paper B. Romanov K., N. Bunyatyan D., Yu. Olefir V., V. Bondarev P., A. Prokofyev B., R. Yagudina I., R. Alyautdin N., E. Kovaleva L., A. Pereverzev P., K. Zatolochina E., A. Kazakov S., A. Komratov V., E. Pasternak Yu., Б. Романов К., Н. Бунятян Д., Ю. Олефир В., В. Бондарев П., А. Прокофьев Б., Р. Ягудина И., Р. Аляутдин Н., Е. Ковалева Л., А. Переверзев П., К. Затолочина Э., А. Казаков С., А. Комратов В., Е. Пастернак Ю. (2018) “Рекомендации по порядку определения взаимозаменяемости лекарственных препаратов // Recommendations on the procedure for determining the interchangeability of medicinal products” / spz:neicon:vedomostincesmp:y:2015:i:2:p:3-8

1
The Federal law 22.12.2014 No 429-FZ «On amending the Federal law “On circulation of medicinal products”» (in Russian).
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2
Summary report of the evaluation of regulatory impact. Available from: http://regulation.gov.ru/project/22466.html (cited 2015 Jan 12) (in Russian).
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3
The Federal law 12.04.2010 No 61-FZ (as amended on 22.10.2014) "On circulation of medicinal products" (var. and additional) (in Russian).
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4
Mironov AN, Vasiliev AN, Gavrishina EV, Niyazov RR. Interchangeability of drugs: international experience, the obstacles and the establishment of the concept in Russia, the role of scientific expertise. Remedium 2013; (10): 8–17 (in Russian).
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5
Lepakhin V.K., Romanov B.K., Nikitina T.N., Snegiryova I.I. Expert evaluation of risk-benefit analysis of drugs. Scientific Centre for Expert Evaluation of Medicinal Products Bulletin 2012; 2: 19-21 (in Russian).
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6
Truus Janse-de Hoog. Interchangeability of generics. European Medicines Agency. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2011/06/ WC500107873.pdf (cited 2015 Jan 12).
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7
Approved Drug Products with Therapeutic Equivalence Evaluations, 34nd (2014) [Orange Book]. United States Food and Drug Administration. Available from: http://www.accessdata.fda.gov/scripts/cder/ob (cited 2015 Jan 12).
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8
Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009 (Draft Guidance Updated for 508 on 3/22/12). Food and Drug Administration. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm259797.htm (cited 2015 Jan 12).
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