Biocon Limited, a global biopharmaceutical company, has announced the commercial launch of Yesafili™ (aflibercept-jbvf) in the United States. The product is a biosimilar to Eylea® (aflibercept) 2 mg and is used to treat several retinal and ophthalmic diseases, including conditions that can lead to vision loss.
Yesafili previously received approval from the US Food and Drug Administration (FDA) along with an interchangeable designation, allowing pharmacists to substitute the product for the reference medicine in accordance with state regulations. The launch marks another milestone in Biocon’s biosimilars business and expands its portfolio in the ophthalmology segment.
Commenting on the launch, Shreehas Tambe, Chief Executive Officer and Managing Director of Biocon Limited, said, “The commercial launch of Yesafili in the United States is an important milestone in our efforts to improve access to high-quality biosimilar medicines. It strengthens our presence in ophthalmology and reflects our commitment to making advanced treatments more accessible and affordable for patients around the world.”
Age-related macular degeneration (AMD) remains one of the leading causes of vision loss among older adults in the United States. Industry estimates indicate that nearly 19.8 million Americans are living with the condition, highlighting the need for effective and affordable treatment options. The reference product, Eylea, generated approximately US$5.89 billion in US sales during 2023, making it one of the largest therapies in the ophthalmology market.
The FDA approval of Yesafili was supported by a comprehensive package of analytical, non-clinical and clinical data demonstrating that the biosimilar is highly similar to the reference product. The Phase 3 INSIGHT clinical study evaluated Yesafili in patients with diabetic macular edema and confirmed that it delivers comparable pharmacokinetics, safety, efficacy and immunogenicity to Eylea 2 mg, with no clinically meaningful differences between the two products.
The commercial launch further strengthens Biocon’s global biosimilars portfolio and reflects the company’s continued investment in developing complex biologic medicines for patients with chronic diseases. The company remains focused on expanding access to affordable therapies across major healthcare markets while supporting healthcare systems with high-quality treatment alternatives.
With a growing presence in the global biosimilars market, Biocon continues to invest in research, development and advanced manufacturing capabilities to address unmet medical needs in areas such as diabetes, oncology, immunology, ophthalmology, cardiovascular diseases and other chronic conditions. The launch of Yesafili reinforces the company’s strategy of delivering innovative and affordable biologic medicines to patients worldwide.
Biocon Limited is a global biopharmaceutical company committed to developing affordable, life-changing medicines for patients worldwide. Headquartered in Bengaluru, India, the company focuses on biosimilars, generic formulations and innovative therapies for chronic and non-communicable diseases. Its portfolio covers key therapeutic areas including diabetes, oncology, immunology, cardiovascular diseases, obesity, ophthalmology and bone health.
Biocon has commercialized 12 biosimilars and more than 30 generic products globally and maintains a pipeline of over 20 biosimilar candidates along with GLP-1 peptides and other complex generics. Operating in more than 120 countries, the company is supported by seven manufacturing facilities, three research and development centres, 18 global offices and a workforce of over 9,500 employees. Biocon was included in the S&P Global Sustainability Yearbook 2026 for the fourth consecutive year, reflecting its commitment to sustainable growth and responsible healthcare innovation.
