Biosimilars (or follow-on biologics) are a new class of medicine which enters\r\nthe market subsequent to a previously approved version. They have demonstrated\r\nsimilarity to innovator biologic products in terms of quality, safety, and efficacy. The EMA\r\nhas taken the lead in the regulatory approval framework for biosimilar products, and WHO\r\nhas published guidelines on the evaluation of biosimilars in order to facilitate the global\r\nharmonization. Based on EMA and WHO guidelines, many other countries such as\r\nCanada, Japan and Korea have also issued their own guidance for evaluating follow-on\r\nbiologics. The US FDA was authorized to approve follow-on biologics by the BPCI Act\r\npassed by the US Congress on March 23, 2010, and has just issued a draft guidance in\r\nearly 2012. The basic concepts and main principles of approving biosimilars are similar\r\namong various nations, notwithstanding some differences in regard to the scope, the choice\r\nof reference product, and the data requirement. This article reviews the regulatory approval\r\npathway of biosimilar products in different regions.
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