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.
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Final review documents have been posted for only four of 12 biosimilars due to a backlog in applications considered the third priority level for redaction – a categorization that seems out of sync with the agency’s approach to labeling and its emphasis on promoting price competition.
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.
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.