The Big Molecule Watch is monitoring pending legislation in Congress that relates to biosimilars and biologics. In this post, we check in on the status of two currently pending bills related to Citizen Petitions. The first is H.R. 2883, Stop Stalling Access to Affordable Medications, which aims to stop the…
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…