Biosimilar Hearing Will Consider Whether 'Umbrella' Exclusivity Policy Warranted
US FDA asks for comments on whether the policy employed for small molecule generics also should apply to biosimilars.
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US FDA Gets Earful On Biologic ‘Umbrella’ Exclusivity, Patent Listings, Biosimilar Bridging Study Waivers
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.