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Expert Analysis

FDA's Biosimilar Rules Will Provide Testing Clarity

Law360, New York (May 27, 2014, 3:43 PM EDT) -- The U.S. Food and Drug Administration's biosimilars guidances provide some rules of the road for successfully navigating the highway to approval of a biosimilars application under Section 351. The FDA's newest draft guidance on demonstrating biosimilarity reiterates aspects of the agency's past guidance on the subject, but it also offers a bit more insight on its current thinking regarding the stepwise clinical testing approach that it expects to see from applicants. Early and frequent discussions with the FDA regarding planned clinical studies remain key in order to best position an application for approval....

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