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

Executive Summary

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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Listing patent and exclusivity information for novel biologics, as is done in the ‘Orange Book’ for small molecules, would help inform biosimilar development, stakeholders say at hearing on facilitating biologic competition and innovation; AbbVie urges FDA to use the Purple Book to clarify the scope of interchangeability decisions.

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