FDA releases draft guidelines for biosimilars

02/9/2012 | Reuters · Bloomberg Businessweek

The FDA has issued draft guidelines for the approval of biosimilar drugs. The proposal would require companies to submit data from laboratory and clinical studies showing that biosimilars are "highly similar" to the original drugs. The Generic Pharmaceutical Association is pleased with the FDA's move, saying the guidance is a significant step toward the delivery of "affordable, lifesaving medicines into the hands of doctors and patients."

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