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.
Subscribers can read the full article at law360.com.
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