BRIDGEWATER, N.J. — Biocon has commercially launched Yesafili, its biosimilar to Regeneron’s Eylea 2 mg, in the United States.
Yesafili, or aflibercept-jbvf, is a vascular endothelial growth factor inhibitor used to treat several serious eye conditions. The U.S. Food and Drug Administration approved the product and granted it interchangeable biosimilar status in May 2024.
The interchangeable designation allows pharmacists to substitute Yesafili for Eylea in accordance with applicable state laws.
“The launch of Yesafili in the U.S. 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.
Tambe said the launch strengthens Biocon’s ophthalmology business and expands access to treatment for patients with retinal diseases.
Biocon said an estimated 19.8 million Americans are living with age-related macular degeneration. The condition is a leading cause of irreversible vision loss among adults over age 60.
U.S. sales of aflibercept reached approximately $5.89 billion in 2023, according to the company.
The FDA approval of Yesafili was supported by analytical, nonclinical and clinical data showing that the product is highly similar to Eylea 2 mg.
In the Phase 3 INSIGHT study, Yesafili was compared with Eylea in patients with diabetic macular edema. Biocon said the study found no clinically meaningful differences between the products in pharmacokinetics, safety, efficacy or immunogenicity.
