US FDA Gets Earful On Biologic ‘Umbrella’ Exclusivity, Patent Listings, Biosimilar Bridging Study Waivers

 
• By Sue Sutter

BIO and PhRMA want an exclusivity policy that protects subsequent changes to innovator biologics and oppose patent listings in the Purple Book; AAM says agency should waive unnecessary clinical bridging studies based on information provided under confidentiality agreements with foreign regulators.

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US FDA heard plenty of feedback from industry trade groups on issues involving biosimilar competition and product innovation.

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