Biocon has announced the commercial launch of Yesafili (aflibercept-jbvf), a biosimilar to Regeneron’s Eylea 2 mg, in the United States.
Yesafili is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of various serious eyeconditions, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
In May 2024, the US Food and Drug Administration approved the product and granted interchangeable designation, allowing substitution at the pharmacy level in accordance with state laws.
The approval was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that Yesafili is highly similar to Eylea 2 mg. A Phase 3 INSIGHT Study involving patients with diabetic macular edema found no clinically meaningful differences between Yesafili and Eylea 2 mg in terms of pharmacokinetics, safety, efficacy and immunogenicity.
Shreehas Tambe, CEO & Managing Director, Biocon, said the launch marks an important step in expanding the global availability of biosimilar Aflibercept 2 mg for patients with eye conditions.
“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,” he added.
Age-related macular degeneration (AMD) is a leading cause of irreversible vision loss among adults aged 60 and older. In 2019, an estimated 19.8 million (12.6%) Americans aged 40 years and older were living with AMD, including approximately 1.49 million (0.94%) with vision-threatening disease.
US sales of aflibercept reached approximately $5.89 billion in 2023, underscoring the strong demand for effective treatment options in retinal diseases.
