Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced that it has received marketing approval from the European Commission (EC) for its biosimilar of Bayer/Regeneron’s (ETR: BAYN / NASDAQ: REGN) Eylea (aflibercept). The product is now available in the form of a 2 mg vial kit and pre-filled syringe for intravitreal injection under the trade names Afqlir in the European Union (EU) and Enzeevu in the US. This development marks a significant expansion in the treatment options for various retinal diseases, including neovascular age-related macular degeneration (nAMD), aiming to prevent disease-related blindness.
Eylea and Its Biosimilars: A Focus on Retinal Health
Eylea, a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), was first approved in the US in November 2011. Since then, the originator product has received indications for a range of eye diseases, including neovascular age-related macular degeneration (AMD), retinal vein occlusion, diabetes retinopathy, and other retinal conditions.
US FDA Approvals and EC Recommendations
In May 2024, the US FDA approved Mylan Pharmaceuticals Inc., and Biocon Biologics’ Yesafili, and Samsung Bioepis’ Opuviz as interchangeable biosimilars to Eylea. Enzeevu, Sandoz’s biosimilar, earned its marketing nod in the US in August 2024, followed by a recommendation for marketing approval by the EC one month later. These approvals underscore the growing acceptance and availability of biosimilars as cost-effective alternatives to originator biologics, potentially improving access to treatment for patients with retinal diseases.-Fineline Info & Tech
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