Biocon Launches Yesafili™ Biosimilar in the U.S., Expands Presence in Ophthalmology Market
Biocon Limited has announced the commercial launch of Yesafili™ (aflibercept-jbvf) in the United States, marking a significant milestone in its global biosimilars business. The product is an FDA-approved interchangeable biosimilar to Eylea® (aflibercept) 2 mg, a leading treatment for several serious retinal diseases.
The launch reinforces Biocon’s commitment to expanding access to affordable biologic medicines while strengthening its position in the high-value ophthalmology segment.
Key Highlights
- Product: Yesafili™ (aflibercept-jbvf)
- Launch Date: August 3, 2026
- Category: Biosimilar
- Market: United States
- Reference Medicine: Eylea® (aflibercept) 2 mg
- Regulatory Status: U.S. FDA-approved interchangeable biosimilar
Expanding Access to Vision Care
Yesafili™ is a vascular endothelial growth factor (VEGF) inhibitor designed to treat several serious eye disorders that can lead to vision loss. The biosimilar received U.S. FDA approval with interchangeable designation, allowing pharmacy-level substitution where permitted under state regulations.
According to Biocon, the commercial launch represents another step toward improving patient access to affordable biologic therapies in one of the world’s largest pharmaceutical markets.
Management Commentary
Shreehas Tambe, CEO and Managing Director of Biocon Limited, said the U.S. launch of Yesafili™ marks an important milestone in expanding the availability of biosimilar aflibercept for patients suffering from retinal diseases. He added that the launch strengthens Biocon’s ophthalmology portfolio and builds on the company’s achievement of receiving one of the first interchangeable biosimilar approvals for Eylea® 2 mg in the United States.
Large Market Opportunity
The launch targets a sizeable ophthalmology market in the United States.
According to the company:
- Nearly 20 million Americans are living with age-related macular degeneration (AMD).
- Approximately 1.5 million people suffer from vision-threatening AMD.
- Sales of the reference drug Eylea® reached approximately US$5.89 billion in 2023, highlighting strong demand for effective treatment options.
The growing prevalence of retinal diseases, coupled with increasing healthcare costs, creates significant opportunities for biosimilars that offer comparable clinical outcomes at potentially lower costs.
Approved Indications
Yesafili™ is indicated for the treatment of multiple retinal disorders, including:
- Wet Age-Related Macular Degeneration (AMD)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR)
- Macular Edema following Retinal Vein Occlusion (RVO)
These conditions are among the leading causes of vision impairment globally.
Clinical Development
Biocon stated that FDA approval was supported by an extensive package of analytical, non-clinical, and clinical evidence demonstrating that Yesafili™ is highly similar to the reference medicine.
The Phase III INSIGHT clinical study compared Yesafili™ with Eylea® in patients with diabetic macular edema and demonstrated no clinically meaningful differences in:
- Safety
- Efficacy
- Pharmacokinetics
- Immunogenicity
Strengthening Biocon’s Biosimilars Leadership
The U.S. launch further enhances Biocon’s growing global biosimilars portfolio. The company has established itself as one of the leading biosimilar manufacturers worldwide, with:
- 12 commercialized biosimilar products
- More than 30 generic formulations marketed globally
- Presence across over 120 countries
- A research pipeline of more than 20 biosimilar candidates
Biocon continues to focus on key therapeutic areas including diabetes, oncology, immunology, ophthalmology, obesity, cardiovascular diseases, and bone health.