Biocon Biologics Signs Patent Settlement with Bayer Inc and Regeneron Pharmaceuticals Inc, Allowing Launch of Biosimilar Product in Canada
Biocon Biologics announced on Monday that it has reached a patent settlement agreement with Bayer Inc and Regeneron Pharmaceuticals Inc, paving the way for the launch of a biosimilar product in Canada.
The settlement agreement facilitates the introduction of Yesafili, a proposed biosimilar to Eylea (aflibercept) injection, into the Canadian market, as stated in a regulatory filing by Biocon Biologics.
According to the terms of the agreement, Biocon Biologics has secured a launch date for Yesafili no later than July 1, 2025.
Yesafili, an ophthalmology product, is designed for the treatment of neovascular (wet AMD), age-related macular degeneration, among other conditions. Health Canada had granted tentative approval for Yesafili (2 mg vials) in March 2023, contingent upon the resolution of any patent issues, Biocon Biologics reported.
The settlement resolves various parallel patent infringement proceedings in the Federal Court of Canada involving six patents, along with associated judicial review proceedings under Canada’s Patented Medicines (Notice of Compliance) Regulations addressing pre-entry pharmaceutical patent litigation, the company noted.
