FDA Releases Draft Guidance on Biosimilars

02 April 2012 Pharmaceutical Compliance Monitor Publication
Authors: Courtenay C. Brinckerhoff

Pharmaceutical Compliance Monitor

Partner Courtenay Brinckerhoff stated that the Food and Drug Administration’s draft guidance on biosimilars answers basic questions that may arise in the early stages of product development, including how to meet with the FDA and request exclusivity. Brinckerhoff also said the guidance outlines a stepwise approach to developing products that will require clinical studies and information demonstrating biosimilarity. 

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