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FDA Biosimilar Guidances Stir Innovator Worries About BLA Exclusivity, Trade Secrets

Executive Summary

Brand pharma/biotech stakeholders say that BLA sponsors should not have to request and justify the award of 12 years of innovator exclusivity, as FDA’s draft guidance suggests. They also raise concerns about disclosure of BLA trade secrets, with Abbott asserting that approval of biosimilars that reference products licensed before March 2010 would constitute a “taking.”

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