FDA Allows Greater Flexibility for Biosimilar Licensing, Expert Says

Companies seeking to market biosimilars may have more success getting their products approved in the U.S. than in other highly regulated markets, thanks to the FDA’s “step-wise” guidance. That’s the opinion of Covington & Burling attorney Richard Kingham, who discussed similarities and differences in biosimilars regulation in the U.S., EU and elsewhere during a recent Food & Drug Law Institute webinar.
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