- Yesafili™ (aflibercept-jbvf) now available in the United States as an U.S. FDA-approved interchangeable biosimilar to EYLEA 2 mg
- Potential benefit to the ~20 million adults in the U.S. with age-related macular degeneration and other serious eye conditions
BENGALURU, India and BRIDGEWATER, N.J., United States: August 3, 2026
Biocon Limited (BSE: 532523; NSE: BIOCON), an innovation‑led global biopharmaceutical company, today announced the commercial launch of Yesafili™ (aflibercept-jbvf) in the United States. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat various types of ophthalmology conditions, is a biosimilar of its reference product EYLEA® (aflibercept) 2 mg. The product was approved previously and granted interchangeable designation* by the U.S. Food and Drug Administration in May 2024, allowing substitution at the pharmacy level in accordance with state laws.
Shreehas Tambe, CEO & Managing Director, Biocon Ltd., said, “The launch of Yesafili™️ in the U.S. marks an important step in expanding the global availability of biosimilar Aflibercept 2 mg for patients with eye conditions. This milestone further strengthens our presence in ophthalmology and builds on our FDA approval as one of the first interchangeable biosimilars to Eylea®️ 2 mg, advancing access to life-changing medicines for patients around the world.”
An estimated 19.8 million Americans are living with age-related macular degeneration (AMD) while U.S.[1] sales of aflibercept reached approximately $5.89 billion in 2023,[2] underscoring the growing need for effective treatment options.
Epidemiology:
Macular degeneration, specifically age-related macular degeneration (AMD), is a significant health concern, especially as the population ages. It is a leading cause of irreversible vision loss in adults over 60[3]. In 2019, an estimated 19.8 million (12.6%) Americans aged 40 and older were living with AMD, with 1.49 million (0.94%) living with vision threatening.[4]
About YESAFILI (aflibercept-jbvf)
The approval for YESAFILI (aflibercept-jbvf) was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that YESAFILI is highly similar to Eylea® 2 mg. In a Phase 3 INSIGHT Study, YESAFILI was compared with Eylea® 2 mg in patients with Diabetic Macular Edema. Study demonstrated that there were no clinically meaningful differences between YESAFILI and Eylea 2 mg in terms of pharmacokinetics, safety, efficacy, and immunogenicity.
INDICATIONS AND USAGE:
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)
WARNINGS AND PRECAUTIONS:
- YESAFILI is contraindicated in patients with Ocular or periocular infection, Active intraocular inflammation and Hypersensitivity to aflibercept.
- Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
- Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
- There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
Please refer to the full Patient Information for detailed safety information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon at 1-833-986-1468.
About Biocon Limited
Biocon Limited (BSE: 532523, NSE: BIOCON) is a global biopharmaceutical company driven by its purpose to provide affordable, life-changing medicines to patients worldwide. Headquartered in Bengaluru, India, Biocon addresses some of the world’s most pressing healthcare challenges across chronic and non-communicable diseases by offering both biosimilars and generics at scale across geographies. Through this diversified portfolio, Biocon focuses on areas of high unmet need, spanning key therapy areas including diabetes, oncology, obesity, cardiovascular diseases, immunology, ophthalmology, and bone health. The Company has pioneered several industry firsts that have helped shape the global biosimilars landscape. To date, the company has commercialized 12 biosimilar products and 30+ generic formulations globally. It has robust research and development pipeline of 20+ biosimilar assets, as well as GLP-1 peptides and other complex generics. With an integrated lab-to-patient model, Biocon brings together research and development, manufacturing, and commercial capabilities to ensure reliable and scalable supply of medicines. The company operates in more than 120 countries, supported by seven manufacturing sites, three R&D sites, 18 offices worldwide, and a workforce of over 9,500 employees. Biocon has been included in the S&P Global Sustainability Yearbook 2026 for the fourth consecutive year, underscoring its commitment to sustainable and responsible growth. Website: www.biocon.com Follow us on X: @bioconlimited LinkedIn: Biocon
Forward-Looking Statements: Biocon
This press release may include statements of future expectations and other forward-looking statements based on management’s current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release.
Yesafili™ is a trademark of Biocon Biologics Limited.
BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited.
BIOCON and the Biocon Logo are registered trademarks of Biocon Limited.
All other trademarks, registered or unregistered, are the property of their respective owners.
* Vial is interchangeable. Pre-filled syringe has provisional interchangeability status.
[2] Regeneron Fourth Quarter and Full Year 2023 Financial and Operating Results. February 2, 2024.
[3] Macular Degeneration: Symptoms, Diagnosis & Treatment
[4] VEHSS Modeled Estimates: Age-Related Macular Degeneration (AMD) | Vision and Eye Health Surveillance System (VEHSS) | CDC
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