Biocon Biologics Ltd (BBL), a globally integrated biosimilars company and a subsidiary of Biocon Ltd, on Monday announced the signing of a settlement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. This agreement, it added, 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,” the company said in a statement.
Earlier in February, Biocon had reported a consolidated net profit of Rs 660 crore for the third quarter ended December 31, 2023, on the back of robust sales. The company had reported a net loss of Rs 42 crore in the October-December period of last fiscal. Total revenue was at Rs 4,519 crore in the third quarter as against Rs 3,020 crore in the year-ago period.
