Key Takeaways

  • Biocon has commercially launched Yesafili (aflibercept-jbvf), an FDA-approved interchangeable biosimilar to Eylea 2 mg, in the United States.
  • The approval was supported by the Phase 3 INSIGHT trial, which demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to reference aflibercept in patients with DME

Biocon announced the commercial launch of Yesafili (aflibercept-jbvf) in the United States, expanding the availability of an interchangeable biosimilar to Eylea (aflibercept) 2 mg for the treatment of retinal vascular diseases.

The FDA approved Yesafili in May 2024 and granted the product interchangeable designation, allowing pharmacy-level substitution for the reference product.

Yesafili is a vascular endothelial growth factor (VEGF) inhibitor indicated for the same ophthalmic conditions as reference aflibercept 2 mg, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy, macular edema following retinal vein occlusion (RVO), and retinopathy of prematurity (ROP).

"The launch of Yesafili in the US marks an important step in expanding the global availability of biosimilar aflibercept 2 mg for patients with eye conditions," said Shreehas Tambe, CEO and managing director of Biocon. "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."

FDA approval of Yesafili was supported by a comprehensive analytical, nonclinical, and clinical development program demonstrating biosimilarity to reference aflibercept 2 mg, according to Biocon.

The pivotal phase 3 INSIGHT trial evaluated Yesafili in patients with diabetic macular edema, comparing the biosimilar with reference aflibercept. According to Biocon, the study demonstrated no clinically meaningful differences between the two products in pharmacokinetics, efficacy, safety, or immunogenicity, supporting the biosimilar's approval and interchangeable designation.