US Biosimilar Guidelines: Summary and Insights

Posted 03 April 2012 By Kamali Chance, MPH, PhD, RAC

In March 2010, section 351(a) of the Public Health Service Act was amended to create an abbreviated pathway for the approval of biosimilars or interchangeable biologic products that were found to be highly similar to US Food and Drug Administration (FDA) licensed biologics. This article explores recent FDA guidance pertaining to biosimilar products.

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Categories: Features, FDA

Tags: Biosimilarity, Biogenerics, biosimilar, guidance, Biosimilars, Follow-on Biologics, Biologics

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