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Pharmaceuticals 2012, 5(4), 353-368;

On the Regulatory Approval Pathway of Biosimilar Products

Duke University School of Medicine, DUMC 3813, Durham, NC 27710, USA
Duke University School of Medicine, Duke Box 2721, Durham, NC 27710, USA
Author to whom correspondence should be addressed.
Received: 20 February 2012 / Revised: 20 March 2012 / Accepted: 28 March 2012 / Published: 30 March 2012
(This article belongs to the Special Issue Biologics)
Full-Text   |   PDF [97 KB, uploaded 30 March 2012]


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to approve follow-on biologics by the BPCI Act passed by the US Congress on March 23, 2010, and has just issued a draft guidance in early 2012.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. View Full-Text
Keywords: biosimilars; biosimilarity; interchangeability; WHO; EMA; FDA biosimilars; biosimilarity; interchangeability; WHO; EMA; FDA
This is an open access article distributed under the Creative Commons Attribution License (CC BY 3.0).

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Wang, J.; Chow, S.-C. On the Regulatory Approval Pathway of Biosimilar Products. Pharmaceuticals 2012, 5, 353-368.

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