Biocon Ltd has commercially launched Yesafili, its interchangeable biosimilar to blockbuster eye drug Eylea (aflibercept) 2 mg, in the United States, marking a significant expansion of its ophthalmology portfolio in the world’s largest pharmaceutical market.
Yesafili is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of various retinal disorders, including age-related macular degeneration (AMD) and diabetic macular edema. The product had received approval from the US Food and Drug Administration (FDA) in May 2024, along with an interchangeable designation, enabling pharmacists to substitute it for the reference product in accordance with state pharmacy laws.
The launch comes as demand for retinal disease treatments continues to rise. According to Biocon, nearly 19.8 million Americans aged 40 years and above are living with age-related macular degeneration, while around 1.49 million suffer from vision-threatening forms of the disease. The reference drug, Eylea, generated approximately $5.89 billion in US sales in 2023.
Strengthening ophthalmology presence
Biocon Ltd CEO & Managing Director Shreehas Tambe said the commercial rollout reinforces the company’s commitment to expanding patient access to affordable biologic therapies.
“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,” he said.
Backed by Phase 3 data
Biocon said the FDA approval was supported by a comprehensive package of analytical, non-clinical and clinical evidence demonstrating that Yesafili is highly similar to Eylea 2 mg.
The pivotal Phase 3 INSIGHT study, conducted in patients with diabetic macular edema, showed no clinically meaningful differences between Yesafili and the reference product in terms of pharmacokinetics, efficacy, safety and immunogenicity.
With the US launch, Biocon is looking to strengthen its biosimilars business by tapping into the large and growing ophthalmology market while offering a potentially lower-cost treatment alternative for patients and healthcare providers.