BENGALURU, India, and BRIDGEWATER, N.J., Aug. 3, 2026
Biocon Limited has announced the U.S. commercial launch of Yesafili™ (aflibercept-jbvf), an FDA-approved interchangeable biosimilar to Regeneron’s Eylea® (aflibercept) 2 mg, expanding treatment options for patients with serious retinal diseases. Yesafili™ previously received U.S. Food and Drug Administration (FDA) approval with interchangeable designation in May 2024, allowing pharmacists to substitute it for the reference product where permitted under state laws. The launch strengthens Biocon’s ophthalmology portfolio while improving patient access to more affordable biologic therapies. The company estimates the product could benefit nearly 20 million adults in the United States affected by age-related macular degeneration (AMD) and other vision-threatening retinal disorders. The commercial milestone also reinforces Biocon’s growing position in the global biosimilars market by introducing one of the first interchangeable aflibercept biosimilars available in the U.S.
FDA-Approved Interchangeable Biosimilar Expands Access to Eye Care
Yesafili™ (aflibercept-jbvf) is a vascular endothelial growth factor (VEGF) inhibitor approved for treating several retinal diseases, including neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO). The FDA’s interchangeable designation allows eligible pharmacies to substitute the biosimilar for Eylea® 2 mg according to applicable state regulations, potentially improving treatment accessibility and reducing healthcare costs. According to Biocon, approximately 19.8 million Americans are living with AMD, one of the leading causes of irreversible vision loss among older adults, highlighting the need for broader access to effective anti-VEGF therapies. The commercial launch further expands treatment choices for ophthalmologists and patients managing chronic retinal diseases.
Clinical Evidence Demonstrated Comparable Safety and Efficacy
The FDA approval of Yesafili™ was supported by a comprehensive package of analytical, nonclinical, and clinical data confirming high similarity to Eylea® 2 mg. The pivotal Phase 3 INSIGHT clinical trial, conducted in patients with diabetic macular edema, demonstrated no clinically meaningful differences between the biosimilar and the reference medicine in terms of pharmacokinetics, efficacy, safety, and immunogenicity. As with other intravitreal VEGF inhibitors, important safety considerations include the risks of endophthalmitis, retinal detachment, retinal vasculitis, increased intraocular pressure, and arterial thromboembolic events, requiring careful patient monitoring following treatment. The robust clinical evidence supported the product’s approval as an interchangeable biosimilar capable of delivering equivalent clinical outcomes.
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Launch Strengthens Biocon’s Global Biosimilars Portfolio
The U.S. launch of Yesafili™ marks another significant milestone in Biocon’s global biosimilars strategy, expanding the company’s presence in the ophthalmology market while reinforcing its leadership in affordable biologic medicines. Biocon has now commercialized 12 biosimilar products and more than 30 generic formulations globally, supported by a development pipeline of over 20 biosimilar candidates spanning multiple therapeutic areas. Operating in more than 120 countries, the company continues to invest in innovative biologics, complex generics, and peptide therapies addressing chronic diseases including diabetes, oncology, cardiovascular disease, obesity, immunology, ophthalmology, and bone health. The commercial availability of Yesafili™ further strengthens Biocon’s commitment to expanding patient access to high-quality, cost-effective biosimilars while supporting healthcare systems worldwide.
Source: Biocon press release
