FDA Approves Two Eylea Biosimilars

The FDA has given the green light to two biosimilars of Regeneron Pharmaceuticals' Eylea (aflibercept) – Biocon Biologics’ Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy). Both Yesafili and Opuviz have received the FDA's interchangeability designation, which allows them to be substituted for the original product without consulting the prescriber, as per the FDA's announcement.

The launch dates and pricing for these two biosimilars in the U.S. remain uncertain. However, Biocon has confirmed that Yesafili will be available in Canada by July 1, 2025, under a settlement agreement. Like Eylea, Yesafili and Opuviz are administered through intravitreal injections and are approved for conditions such as wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic retinopathy, and diabetic macular edema.

The FDA's approval followed an extensive review of data demonstrating that Yesafili and Opuviz are highly similar to Eylea, with no significant clinical differences. This includes physicochemical and biological tests confirming structural and functional similarities to Eylea. Comparative clinical data also indicated that the biosimilars match Eylea in terms of efficacy, safety, and immunogenicity.

Eylea functions as a soluble decoy receptor that binds to VEGF-A and PIGF ligands, preventing them from activating their receptors and thereby inhibiting abnormal blood vessel growth in the eyes. In the U.S., Regeneron exclusively commercializes Eylea, while outside the country, it is partnered with Bayer, with profits shared equally.

Initially approved by the FDA in 2011 for treating wet age-related macular degeneration, Eylea has since gained approval for several other indications. It has become one of Regeneron’s top-performing products, with global sales reaching $9.2 billion in 2021 and increasing to $9.6 billion in 2022. 

However, Eylea's sales saw a decline in 2023, dropping to nearly $9.4 billion. This dip is primarily attributed to stiff competition from Roche’s Vabysmo (faricimab-svoa). With key patent protections for Eylea set to expire this year, Regeneron has been actively defending its market position through various lawsuits. In December 2023, Regeneron won a case against Viatris, preventing its biosimilar from entering the U.S. market until 2027. Regeneron also has ongoing litigation against Samsung Biologics.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!