On the regulatory approval pathway of biosimilar products.

Published online

Journal Article

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to approve follow-on biologics by the BPCI Act passed by the US Congress on March 23, 2010, and has just issued a draft guidance in early 2012.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.

Full Text

Duke Authors

Cited Authors

  • Wang, J; Chow, S-C

Published Date

  • March 30, 2012

Published In

Volume / Issue

  • 5 / 4

Start / End Page

  • 353 - 368

PubMed ID

  • 24281406

Pubmed Central ID

  • 24281406

International Standard Serial Number (ISSN)

  • 1424-8247

Digital Object Identifier (DOI)

  • 10.3390/ph5040353

Language

  • eng

Conference Location

  • Switzerland