Yesafili is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of several retinal eye disorders and is a biosimilar to EYLEA (aflibercept) 2 mg. The product received approval from the U.S. Food and Drug Administration (USFDA) in May 2024 and was granted an interchangeable designation, allowing pharmacists to substitute it for the reference product in accordance with applicable state laws.
Commenting on the launch, 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."
According to the company, nearly 19.8 million Americans are living with age-related macular degeneration (AMD), one of the leading causes of irreversible vision loss among older adults. U.S. sales of aflibercept reached approximately USD 5.89 billion in 2023, highlighting the significant demand for therapies targeting retinal diseases.
The USFDA approval of Yesafili was supported by a comprehensive package of analytical, non-clinical and clinical evidence demonstrating that the biosimilar is highly similar to EYLEA 2 mg.
Biocon said its Phase III INSIGHT study, conducted in patients with diabetic macular edema (DME), showed no clinically meaningful differences between Yesafili and the reference product in terms of pharmacokinetics, efficacy, safety and immunogenicity.
Yesafili is indicated in the U.S. for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).
The company also highlighted important safety information, noting that the medicine is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or hypersensitivity to aflibercept. As with other intravitreal VEGF inhibitors, the product carries warnings regarding endophthalmitis, retinal detachment, retinal vasculitis, increased intraocular pressure, and the potential risk of arterial thromboembolic events.
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