Biocon Biologics inks licence agreement with Regeneron to commercialise Yesafili

Biocon Biologics Ltd (BBL), the biosimilars company and subsidiary of Biocon Ltd, has announced a licence agreement with Regeneron to commercialise Yesafili, a drug used to treat ophthalmological conditions. The agreement allows the company to launch the product in the US in the second half of 2026 or earlier, in certain circumstances.

The companies executed the settlement agreement to dismiss the pending appeal at the United States Court of Appeals for the Federal Circuit (USCAFC) and the pending litigation at the US District Court for the Northern District of West Virginia, Clarksburg Division.

Yesafili is used to treat several ophthalmology conditions such as neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is a biosimilar to its reference product Eylea (aflibercept).

For the approval of its commercial usage, a comprehensive package of analytical, non-clinical and clinical data was conducted which showed that Yesafili has similarities in quality, safety and efficacy to Eylea.

“This settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality aflibercept biosimilar to patients and healthcare providers in the US. As the first-to-file an interchangeable biosimilar to Eylea®, YESAFILI affirms our scientific strength and marks our strategic entry into ophthalmology, expanding our footprint in the US and advancing our mission to increase access to life-changing treatments,” said Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd.

Last year, the company also signed a settlement agreement with Janssen to commercialise Bmab 1200, a biosimilar of Stelara, used for the treatment of psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

The company has brought nine biosimilars from its pipeline of 20 products into major markets such as the US, Europe, Australia, Canada, and Japan. Earlier this month, the company received approval for Jobevne, a cancer treatment drug which became the company’s fourth oncology biosimilar in the US. The company’s stocks were trading at ₹328.95, up by 3.92 per cent as of 15:03 pm on April 15.

(With inputs from bl reporting intern Nethra Sailesh)

Published on April 15, 2025