Biocon Limited , an innovation‑led global biopharmaceutical company,announced the commercial launch of Yesafili™ (aflibercept-jbvf) in the United States. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat various types of ophthalmology conditions, is a biosimilar of its reference product EYLEA® (aflibercept) 2 mg. The product was approved previously and granted interchangeable designation^* by the U.S. Food and Drug Administration in May 2024, allowing substitution at the pharmacy level in accordance with state laws.

This marks an important step in expanding the global availability of biosimilar aflibercept for patients with eye conditions.

Shreehas Tambe, CEO & Managing Director, Biocon Ltd., said, “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. 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.”

An estimated 19.8 million Americans are living with age-related macular degeneration (AMD) while U.S.¹ sales of aflibercept reached approximately $5.89 billion in 2023,² underscoring the growing need for effective treatment options.

Epidemiology:

Macular degeneration, specifically age-related macular degeneration (AMD), is a significant health concern, especially as the population ages. It is a leading cause of irreversible vision loss in adults over 60³. In 2019, an estimated 19.8 million (12.6%) Americans aged 40 and older were living with AMD, with 1.49 million (0.94%) living with vision threatening.⁴

About YESAFILI (aflibercept-jbvf)

The approval for YESAFILI (aflibercept-jbvf) was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that YESAFILI is highly similar to Eylea® 2 mg. In a Phase 3 INSIGHT Study, YESAFILI was compared with Eylea® 2 mg in patients with Diabetic Macular Edema. Study demonstrated that there were no clinically meaningful differences between YESAFILI and Eylea 2 mg in terms of pharmacokinetics, safety, efficacy, and immunogenicity.

INDICATIONS AND USAGE:

YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema Following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)

WARNINGS AND PRECAUTIONS:

• YESAFILI is contraindicated in patients with Ocular or periocular infection, Active intraocular inflammation and Hypersensitivity to aflibercept.
• Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
• Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
• There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.