Open AccessAuthorisation of Non-Innovator Biotherapeutic (Biosimilar) Products in the USA
Author(s) -
А. А. Солдатов,
Ж И Авдеева,
В. П. Бондарев,
В Д Мосягин
Publication year - 2019
Publication title -
biopreparaty. profilaktika, diagnostika, lečenie
Language(s) - English
Resource type - Journals
eISSN - 2619-1156
pISSN - 2221-996X
DOI - 10.30895/2221-996x-2019-19-1-17-27
Subject(s) - biosimilar , innovator , interchangeability , authorization , quality (philosophy) , business , marketing authorization , marketing , risk analysis (engineering) , medicine , engineering , computer science , computer security , finance , mechanical engineering , bioinformatics , philosophy , epistemology , entrepreneurship , biology
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.