Authorisation of Non-Innovator Biotherapeutic (Biosimilar) Products in the USA
https://doi.org/10.30895/2221-996X-2019-19-1-17-27
Abstract
European competent authorities began to elaborate scientific principles of development of non-innovator biotherapeutic (biosimilar) products in the early noughties, and in 2009 these principles were approved at the WHO International Conference in Seoul gathering participants from countries with a well-developed pharmaceutical industry. The USA adopted the law on biosimilar products in 2012, it was based on the documents and recommendations prepared by the EMA and approved by the WHO. In 2015, the FDA published the new revised versions of the guidelines dealing with biosimilar products. The US regulatory requirements for development and authorisation of biosimilar products are based on a step-by-step comparative assessment of biosimilar and innovator products in terms of their quality, efficacy, and safety in accordance with the WHO/EMA recommendations. At the same time the US regulatory requirements differ from those of other national authorities, including EMA (WHO), when it comes to the design of comparative quality studies (studies of products’ physicochemical and biological properties), the assignment of International Non-Proprietary Names and the interchangeability of biosimilar products.
Keywords
biosimilar products,
biosimilars,
extrapolation,
interchangeability,
authorisation of biosimilar products
Funding: The study reported in this publication was carried out as part of a publicly funded research project No. 056-00154-19-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&D public accounting No. AAAA-A18-118021590049-0)
About the Authors
A. A. Soldatov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Doctor of Medical Sciences, Chief Expert of the Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Centre for Evaluation and Control of Medicinal Immunobiological Products
Russian Federation
Doctor of Medical Sciences, Chief Expert of the Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Centre for Evaluation and Control of Medicinal Immunobiological Products
Zh. I. Avdeeva
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Doctor of Medical Sciences, Professor, Chief Expert of the Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Centre for Evaluation and Control of Medicinal Immunobiological Products
Russian Federation
Doctor of Medical Sciences, Professor, Chief Expert of the Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Centre for Evaluation and Control of Medicinal Immunobiological Products
V. P. Bondarev
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Doctor of Medical Sciences, Professor, Director of the Centre for Evaluation and Control of Medicinal Immunobiological Products
Russian Federation
Doctor of Medical Sciences, Professor, Director of the Centre for Evaluation and Control of Medicinal Immunobiological Products
V. D. Mosyagin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Doctor of Medical Sciences, Professor, Head of the Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Centre for Evaluation and Control of Medicinal Immunobiological Products
Russian Federation
Doctor of Medical Sciences, Professor, Head of the Division for Expert Evaluation of Allergenes, Cytokines and other Immunomodulators of the Centre for Evaluation and Control of Medicinal Immunobiological Products
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Review
For citations:
Soldatov A.A., Avdeeva Zh.I., Bondarev V.P., Mosyagin V.D. Authorisation of Non-Innovator Biotherapeutic (Biosimilar) Products in the USA. BIOpreparations. Prevention, Diagnosis, Treatment. 2019;19(1):17-27. (In Russ.) https://doi.org/10.30895/2221-996X-2019-19-1-17-27
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