On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public Health Service Act for parenteral solutions to mean “total drug content,” without regard to concentration. Boehringer Ingelheim maintains that this correction would bring the FDA’s interpretation of “strength” in line with the “clear meaning” of the Biologics Price Competition and Innovation Act (“BCPIA”), increase consistency, and prevent “evergreening”, or extending the lifetime of exclusive rights over a parenteral solution. According to Boehringer Ingelheim, the FDA’s current interpretation of “strength” encourages companies “to use minor concentration changes as an anticompetitive tactic to prevent competition from biosimilar and interchangeable biological products, thereby depriving patients from accessing more affordable biological products, contrary to the goals of the BPCIA.” Boehringer Ingelheim requests in its Citizen Petition that the FDA bring its interpretation in line with the BCPIA by revising applicable FDA guidance documents, and applying this corrected interpretation to pending and approved 351(k) applications, amendments, supplements, and in correspondence.
Boehringer Ingelheim is the marketing authorization holder of Cyltezo®, a biological product that was licensed on August 25, 2017 via a section 351(k) BLA. Pursuant to a publicly announced settlement with Abbvie, Cyltezo® cannot be launched before July 1, 2023. In its Citizen Petition, Boehringer Ingelheim states that “[u]nder the FDA’s current interpretation of ‘strength’, however, no currently approved OC [original concentration] adalimumab product can be considered biosimilar or interchangeable to Humira’s HC [higher concentration] formulation because the products have different concentrations.” Boehringer Ingelheim states that its requested “interpretation of ‘strength’ would give sponsors of adalimumab products with OC formulations, like Cyltezo®, the opportunity to submit a section 351(k) application seeking biosimilarity and/or interchangeability determinations to Humira’s HC formulation”.