Biocon Settles with Bayer and Regeneron, Securing Canada Market Entry Date for Aflibercept Biosimilar

On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept). The settlement resolves multiple patent infringement proceedings in the Federal Court of Canada. Under the agreement, Biocon can launch YESAFILI in Canada no later than July 1, 2025. In March 2023, Health Canada granted tentative approval for YESAFILI 2 mg vials, subject to resolution of any patent disputes.  Extensive cover of U.S. patent litigation related to biosimilars of EYLEA (aflibercept) can be found on the Big Molecule Watch’s BPCIA Litigation Tracker.