Biocon Biologics clears path for biosimilar launch in Canada after patent dispute resolution

4 Mar 2024 , 03:24 AM

In order to market a biosimilar medicine in Canada, Biocon Biologics announced on Monday that it has signed a patent settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals Inc.

According to a regulatory filing from Biocon Biologics, the settlement agreement opens the door for Yesafili, a planned biosimilar of Eeylea (aflibercept) injection, to be sold in Canada.

It further stated that Biocon Biologics has obtained a product launch date under the conditions of the agreement, which is no later than July 1, 2025.

The ophthalmology product Yesafili is designed to treat a variety of conditions, including age-related macular degeneration and neovascular (wet AMD).

According to Biocon Biologics, Health Canada tentatively approved Yesafili (2 mg vials) in March 2023, pending the resolution of any patent concerns.

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

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