The Indian Biotech Leader Expands its Operations in the U.S. Strategically Through the Launch of a New Biosimilar

Over the past year, Biocon delivered a return of 15.51 per cent, while its three-year return stood at -9.75 per cent.

Biocon Biologics Ltd, a subsidiary of Biocon Limited, announced a major achievement through a settlement and license agreement with Regeneron to launch Yesafili in the US market as an interchangeable biosimilar to Eylea. The agreement enables Biocon Biologics to market Yesafili in the United States starting from the second half of 2026. Yesafili functions as a VEGF inhibitor which serves to treat various ophthalmology conditions such as neovascular age-related macular degeneration and diabetic macular edema. The U.S. FDA approved Yesafili in May 2024 after evaluating its high similarity to the reference product Eylea.

Shreehas Tambe the CEO & Managing Director of Biocon Biologics indicated that the settlement enables Biocon Biologics to establish itself among the first organizations offering reliable high-quality aflibercept biosimilars to U.S. patients and healthcare providers. The strategic step represents Biocon Biologics' entry into ophthalmology while it strengthens its U.S. market presence.

Biocon Limited operates as a major biotechnology corporation that specializes in creating biotechnology products as well as delivering research services. The organization conducts business through four core divisions which include Biosimilars and Research Services as well as Generics and Novel Biologics. The Biosimilars business segment led by Biocon Biologics generated about 60 per cent of the company's revenue in FY24 while developing 20 biosimilars aimed at treating oncology, immunology, and diabetes diseases.

Syngene operates under the Research Services segment to deliver comprehensive research and development solutions through partnerships with major pharmaceutical organizations. The Generics segment stands out because it represents the first Indian business that received FDA clearance for manufacturing Lovastatin. The company aims to strengthen its product development through pipeline expansion alongside manufacturing improvements and formulation as well as peptide development. During FY24 the company dedicated 10 per cent of its revenue to research and development activities while also devoting itself to debt reduction because borrowings have risen significantly over time

Biocon Limited traded at Rs 316.55 on April 11, 2025, having touched a 52-week high of Rs 396.85 and a low of Rs 261.70 during the same period. The company holds a market capitalization of Rs 38,005 crore. Over the past year, Biocon delivered a return of 15.51 per cent, while its three-year return stood at -9.75 per cent. The stock is currently valued at a price-to-earnings (PE) ratio of 31.79. Among public shareholders, Arun Suresh Chandavarkar holds a 1.10 per cent stake in the company. The company has been maintaining a healthy dividend payout of 18 per cent.

Investors should keep an eye on this pharma stock.

Disclaimer: The article is for informational purposes only and not investment advice.