Biosimilar Sponsors Say Pharmacokinetic Bridging Studies Should Be The Exception, Not The Norm
US FDA guidance runs risk of creating de facto requirement for bridging studies when a biosimilar applicant seeks to use comparative data involving a foreign reference product, Novartis says; IGBA, AAM urge agency adopt a ‘global comparator’ approach that would eliminate the need for clinical bridging studies between US and foreign reference biologics.
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If agency adopts policy, it might obviate the need for the CREATES Act. Biosimilars already enjoy a degree flexibility of on the source of reference material that generic sponsors want extended to the less complicated small molecule drugs.
Delegates at the recent pre-ICDRA conference heard about the issues dogging the regulation of biosimilar medicines in the Eastern Mediterranean Region, including unfamiliarity with the comparability exercise and a lack of expertise and resources in this area. The question of a "global comparator product" was also raised.
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.