Biosimilar Guidance Silent On Industry's Biggest Questions

Law360, New York (February 10, 2012, 9:27 PM EST) -- The U.S. Food and Drug Administration's newly released guidance on how it will review biosimilars was a relief to an industry that's been waiting two years for clarity. But experts say the guidance is quiet on the details that will determine just how pricey biosimilar development will be.

Biosimilars, the generic versions of biological drugs, have the potential to become a multibillion-dollar industry in the U.S. But in the two years since Congress authorized the FDA to approve biosimilars, the agency has received zero applications for biosimilar approval.

That is due, in part, to a lack of concrete information from the...

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