AFLIBERCEPT-YSZY

The U.S. FDA has approved the first two interchangeable biosimilars to Regeneron's blockbuster eye disorder drug, Eylea. The approvals were granted to Biocon Biologics' Yesafili and Samsung Bioepis and Biogen's Opuviz. The drugs, which are VEGF inhibitors, are approved as 2 mg injections into the eye to treat patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. Opuviz will be marketed by Biogen in the U.S. as part of a 2019 commercialization agreement with Samsung Bioepis, a subsidiary of South Korea's Samsung Biologics. That same agreement also included Byooviz, a biosimilar to Roche's blockbuster eye drug Lucentis, which became the first ophthalmology biosimilar approved in the U.S. in 2021. For Biocon Biologics, a subsidiary of India's Biocon, the approval of Yesafil marks the company's expansion into the ophthalmology therapeutic area in the U.S. Biocon has run into issues with the U.S. regulator in the past, with the agency issuing three Form 483s following inspections of two manufacturing facilities in India back in 2022. First approved in 2011 to treat patients with wet AMD, Regeneron's Eylea, jointly developed with Bayer, has been a best seller for the partners. The original formulation, along with the higher dose version approved last year, brought in net sales of $5.89 billion in 2023.

Pictured: FDA signage at its office in Maryland/iStock, hapabapa The FDA on Monday approved two biosimilars to Regeneron Pharmaceuticals’ blockbuster eye injection Eylea (aflibercept)—Biocon Biologics’ Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy). Yesafili and Opuviz also have the FDA’s interchangeability designation, which means they may be used in place of the reference branded product without needing to consult the prescriber, according to the FDA’s announcement. It is not yet clear when the two biosimilars will launch in the U.S. and what their list prices will be, though Biocon has announced that Yesafili will be available in Canada no later than July 1, 2025, under a settlement agreement. Like the reference product, Yesafili and Opuviz are designed to be administered via an intravitreal injection and are indicated for wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic retinopathy and diabetic macular edema. Monday’s approval follows the FDA’s comprehensive review of data showing that Yesafili and Opuviz are “highly similar to Eylea” and that the biosimilars show “no clinically meaningful differences.” These data include physicochemical and biological tests, which confirmed that the biosimilars were structurally and functionally similar to Eylea, according to the regulator. The FDA also reviewed comparative clinical data, showing that the biosimilars did not differ from Eylea in terms of efficacy, safety and immunogenicity. The reference product Eylea is a soluble decoy receptor that binds both the VEGF-A and PIGF ligands, preventing them from activating their corresponding receptors. This mechanism of action allows Eylea to prevent the abnormal growth of blood vessels in the eyes. While Eylea is exclusively commercialized by Regeneron in the U.S., it is partnered with Bayer outside the country with profits shared equally between the companies. The drug was first approved by the FDA in 2011 for the treatment of wet age-related macular degeneration. Since then, it has won several other indications and has become one of Regeneron’s best-performing assets. In 2021, the eye injection brought in $9.2 billion worldwide, increasing to $9.6 billion the following year. However, in 2023, Eylea sales slipped to nearly $9.4 billion primarily due to strong competition from Roche’s Vabysmo (faricimab-svoa). Key patent protections for Eylea are set to expire this year and Regeneron has been fending off would-be competitors with a spate of lawsuits. In December 2023, it won a case against Viatris keeping the biotech’s biosimilar out of the U.S. until 2027. Regeneron also has a case against Samsung Biologics. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.