Biocon Biologics, the biosimilars arm of Indian pharma giant Biocon, has settled a key patent litigation with US-based Regeneron Pharmaceuticals, clearing the way for the launch of its biosimilar aflibercept — Yesafili — in the United States market by the second half of 2026, or earlier under certain conditions.

Key Highlights

Settlement Finalized in US Court

• Biocon and Regeneron signed a settlement and licensing agreement to resolve litigation related to Yesafili, a biosimilar of Eylea, Regeneron’s blockbuster therapy for eye diseases.

• The pending appeal before the US Court of Appeals for the Federal Circuit and the litigation at the US District Court (West Virginia) will now be dismissed.

Yesafili To Enter US Market by H2 2026

• Under the settlement, Biocon is licensed to commercialize Yesafili in the US in H2 2026, or earlier in specific circumstances.

• Biocon becomes the first to-file interchangeable biosimilar of Eylea, marking its entry into the US ophthalmology market.

Canada Launch Timeline Also Finalized
Biocon has also settled with Bayer and Regeneron in Canada, allowing it to launch Yesafili no later than July 1, 2025.

About Yesafili & Market Potential

• Yesafili is a VEGF inhibitor used to treat eye conditions such as age-related macular degeneration and diabetic retinopathy.

• It is a biosimilar of Eylea, which posted $5.97 billion in global revenue in 2024 according to Regeneron.

• The product is expected to expand Biocon’s biosimilars footprint in the lucrative US ophthalmology segment.

Statements from Leadership
Shreehas Tambe, CEO & MD of Biocon Biologics, said:
“This settlement clears the path for Biocon Biologics and as the first to-file interchangeable biosimilar to Eylea, it marks our strategic entry into Ophthalmology, expanding our footprint in the U.S.”The Biocon-Regeneron settlement reflects Biocon’s aggressive global biosimilar strategy, particularly in high-value segments like ophthalmology. With patent disputes resolved and launch timelines fixed, Yesafili’s US and Canada entry will not only boost Biocon’s international revenue but also offer a cost-effective alternative in the eye care market. The next key watch will be commercial rollout plans and regulatory developments leading up to the 2026 launch.