Biocon Biologics Ltd (BBL), a globally integrated biosimilars company and a subsidiary of Biocon Ltd, has announced the signing of a settlement with Bayer and Regeneron Pharmaceuticals. This agreement paves the way for the introduction of YESAFILI, a proposed biosimilar to EYLEA (aflibercept) Injection, into the Canadian market.

Under the terms of the agreement, Biocon Biologics has secured a launch date for YESAFILI 2 mg NDS for vials and prefilled syringes (yet to be filed), set no later than July 1, 2025. In March 2023, Health Canada had granted tentative approval for YESAFILI 2 mg vials, subject to resolution of any patent issues.

The settlement resolves multiple parallel patent infringement proceedings in the Federal Court of Canada involving six patents, and associated judicial review proceedings, under Canada's Patented Medicines (Notice of Compliance) Regulations addressing pre-entry pharmaceutical patent litigation.