Please use this identifier to cite or link to this item: https://doi.org/10.3390/ph5040353
Title: On the regulatory approval pathway of biosimilar products
Authors: Wang, J
Chow, S.-C 
Keywords: biological product
bioequivalence
biological activity
Canada
clinical evaluation
drug approval
drug efficacy
drug manufacture
drug purity
drug quality
drug research
drug safety
drug stability
European Medicines Agency
European Union
food and drug administration
government regulation
Japan
Korea
medical society
organization
pharmacodynamics
pharmacokinetics
physical chemistry
political participation
practice guideline
review
United States
world health organization
Issue Date: 2012
Citation: Wang, J, Chow, S.-C (2012). On the regulatory approval pathway of biosimilar products. Pharmaceuticals 5 (4) : 353-368. ScholarBank@NUS Repository. https://doi.org/10.3390/ph5040353
Rights: Attribution 4.0 International
Abstract: Biosimilars (or follow-on biologics) are a new class of medicine which enters the market subsequent to a previously approved version. They have demonstrated similarity to innovator biologic products in terms of quality, safety, and efficacy. The EMA has taken the lead in the regulatory approval framework for biosimilar products, and WHO has published guidelines on the evaluation of biosimilars in order to facilitate the global harmonization. Based on EMA and WHO guidelines, many other countries such as Canada, Japan and Korea have also issued their own guidance for evaluating follow-on biologics. The US FDA was authorized to approve follow-on biologics by the BPCI Act passed by the US Congress on March 23, 2010, and has just issued a draft guidance in early 2012. The basic concepts and main principles of approving biosimilars are similar among various nations, notwithstanding some differences in regard to the scope, the choice of reference product, and the data requirement. This article reviews the regulatory approval pathway of biosimilar products in different regions. © 2012 by the authors; licensee MDPI, Basel, Switzerland.
Source Title: Pharmaceuticals
URI: https://scholarbank.nus.edu.sg/handle/10635/180841
ISSN: 1424-8247
DOI: 10.3390/ph5040353
Rights: Attribution 4.0 International
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