Biocon Biologics has begun selling Yesafili in the US, marking its first entry into the American ophthalmology market with an interchangeable biosimilar to Regeneron’s Eylea, following FDA approval and a settlement with the US company.
Biocon Biologics has begun selling Yesafili in the United States, bringing to market an interchangeable biosimilar to Regeneron’s eye drug Eylea after securing a launch window through a settlement with the US company. The move marks Biocon’s entry into the American ophthalmology market and comes more than a year after the US Food and Drug Administration gave the medicine the green light. According to Biocon, the product is now commercially available for patients and providers across the country.
The FDA approved Yesafili, or aflibercept-jbvf, in May 2024 as one of the first interchangeable biosimilars to Eylea 2 mg. It is cleared for several retinal conditions, including neovascular age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy. The agency says aflibercept medicines work by inhibiting vascular endothelial growth factor, helping to curb abnormal blood vessel growth and slow retinal damage.
Biocon said its approval package included the phase 3 INSIGHT study, which compared Yesafili with Eylea in people with diabetic macular oedema. The company said the trial found no clinically meaningful differences between the two medicines in safety, efficacy, pharmacokinetics or immunogenicity. That evidence formed the basis for the biosimilar designation and its interchangeable status in the US.
The launch also reflects a broader push by drugmakers to win a share of the growing biosimilar market in high-cost specialty therapies. In an announcement on its website, Biocon said it had reached an agreement with Regeneron allowing a US launch in the second half of 2026 or earlier under certain circumstances. Chief executive Shreehas Tambe said the debut of Yesafili represented an important step in expanding access to biosimilar aflibercept for patients with eye disease.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
