August 19th 2026
An editorial modeled on Hatch-Waxman proposes an abbreviated FDA pathway granting biosimilars class-level interchangeability to spur competition.
Boehringer Ingelheim Files Citizen Petition to Change FDA's BPCIA Interpretation
December 4th 2020To spur more biosimilar development and reduce anticompetitive practices, the company argued the FDA could improve its interpretation of the term “strength” in the Biologics Price Competition and Innovation Act (BPCIA).