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 1 July 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.

Biocon is an innovation led global biopharmaceuticals company, engaged in the production of therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.

The company had reported consolidated net profit of Rs 660 crore in Q3 FY24 as compared with net loss of Rs 41.8 crore posted in Q3 FY23. Revenue from operations jumped 34.43% year on year (YoY) to Rs 3,953.7 crore in the quarter ended 31 December 2023.