FDA Sheds New Light on Biosimilars Approval Pathway

Paul Calvo, Ph.D. and Timothy Shea, Jr. were quoted in the article in IP Law360 discussing the cautious approach taken by the Food and Drug Administration (FDA). The FDA released a detailed guidance on evidence needed to prove that biosimilars are close matches of their brand-name counterparts, proving more clarity on the scientific expectations that will determine the cost of bringing generic biologics to market.

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