BsUFA III: Industry Eyes Streamlined Review Of New Indications, Phased Review Process
Janssen and Amgen suggest user fee agreement changes aimed at speeding review process for some biosimilar applications and supplements in comments to US FDA on biologic product competition and innovation, while Merck presses agency to clarify its current view on cross-product labeling.
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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.
Carve outs highlight growing problem for industry and FDA – the absence of an expedited process for adding or removing biosimilar indications; Celltrion seeks approval for only three of eight indications on label of reference product, Genentech’s Rituxan, due to intellectual property and exclusivity issues.
US FDA and PhRMA may be headed for showdown over use of foreign reference product bridging studies; PhRMA says that relying on sponsor’s non-public information to waive bridging studies would violate firm’s commercial confidential information, while FDA Commissioner Gottlieb sees ‘public health prerogative’ in considering whether data-sharing agreements with foreign regulators could help eliminate need for unnecessary studies.