Biocon Biologics Resolves Patent Issue With Bayer and Regeneron Pharmaceuticals

Biocon Biologics Resolves Patent Issue With Bayer and Regeneron Pharmaceuticals

It settles multiple parallel infringement proceedings in the court under Patented Medicines (Notice of Compliance) Regulations

Biocon Biologics has stated that it has signed a patent settlement agreement with Bayer Inc and Regeneron Pharmaceuticals Inc, paving the way for launching a biosimilar product in Canada.

The resolution paves the way for introducing Yesafili, a proposed biosimilar to Eeylea (Aflibercept) injection, in the Canadian market. Under the agreement terms, Biocon Biologics has secured a launch date of 01 July 2025 for the product.

Yesafili, an ophthalmology product, is intended to treat neovascular (wet AMD), age-related macular degeneration and other issues.

Biocon Biologics stated that in March 2023, Health Canada had granted a tentative approval for Yesafili (2 mg vials), subject to the resolution of any patent issues.

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