Biocon Limited has intimated the stock exchanges, pursuant to Regulation 30 read with Part A of Schedule III of the SEBI Listing Regulations, regarding the commercial launch of its biosimilar product, Yesafili™ (aflibercept), in the United States.
The disclosure, made via a letter dated August 03, 2026, and signed by Company Secretary Rajesh U. Shanoy, provides the following details as required under SEBI Circular No. HO/49/14/14(7)2025-CFD-POD2/I/3762/2026 dated January 30, 2026:
- Product Name: Yesafili™ (aflibercept)
- Date of Launch: August 03, 2026
- Product Category: Biosimilar
- Market: International market
- Country of Launch: United States
A press release titled "Biocon Announces U.S. Commercial Launch of Yesafili™, a Biosimilar to Regeneron's Eylea® 2 mg" is enclosed with the filing.
Product and Market Details from Press Release
Yesafili™ (aflibercept-jbvf) is now available in the United States as a U.S. FDA-approved interchangeable biosimilar to EYLEA® (aflibercept) 2 mg. The product was approved and granted interchangeable designation by the U.S. Food and Drug Administration in May 2024, which allows for substitution at the pharmacy level in accordance with state laws.
Management Commentary: Shreehas Tambe, CEO & Managing Director of Biocon Ltd., stated that the launch "marks an important step in expanding the global availability of biosimilar Aflibercept 2 mg for patients with eye conditions" and strengthens the company's presence in ophthalmology.
Market Context: The press release cites that U.S. sales of aflibercept reached approximately $5.89 billion in 2023. It is estimated that 19.8 million Americans are living with age-related macular degeneration (AMD), a key condition the product treats.
Clinical Background: The FDA approval for YESAFILI was based on a comprehensive data package. A Phase 3 INSIGHT Study in patients with Diabetic Macular Edema demonstrated no clinically meaningful differences between YESAFILI and Eylea® 2 mg in terms of pharmacokinetics, safety, efficacy, and immunogenicity.
Indications: YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
Contraindications and Warnings: The product is contraindicated in patients with ocular or periocular infection, active intraocular inflammation, and hypersensitivity to aflibercept. Potential risks include endophthalmitis, retinal detachments, retinal vasculitis, increases in intraocular pressure, and a potential risk of arterial thromboembolic events.