FDA In Brief > FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies

FDA In Brief > FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies



FDA takes steps to foster greater efficiency in biosimilar development by reconsidering draft guidance on evaluating analytical studies

Today, the agency withdrew the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017. The draft guidance, if finalized as written, was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and a reference product. After considering public comments that the agency received about the draft guidance, the FDA determined it would withdraw the draft guidance as it gives further consideration to the scientific and regulatory issues involved. Continue reading...