FDA Approves First Interchangeable Biosimilar to Eylea

The U.S. Food and Drug Administration (FDA) has recently sanctioned the first two interchangeable biosimilars to Eylea, a widely-used treatment for several eye disorders developed by Regeneron. The approved biosimilars are Yesafili from Biocon Biologics and Opuviz, a collaborative product from Samsung Bioepis and Biogen. These drugs, which function as VEGF inhibitors, are intended for 2 mg injections to treat conditions such as neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Opuviz will be marketed in the United States by Biogen, thanks to a 2019 commercialization agreement struck with Samsung Bioepis, a subsidiary of South Korea's Samsung Biologics. This agreement also saw the inclusion of Byooviz, a biosimilar to Roche’s successful eye medication Lucentis, which notably became the first ophthalmology biosimilar approved in the U.S. in 2021.

For Biocon Biologics, a subsidiary of India-based Biocon, the approval of Yesafili represents a significant milestone, marking the company's initial foray into the U.S. ophthalmology market. Biocon has previously faced regulatory challenges with the U.S. FDA, which issued three Form 483s following inspections of its manufacturing facilities in India back in 2022. These forms generally indicate observations of potential regulatory violations or compliance issues that need to be addressed.

Regeneron's Eylea, which was first approved in 2011 for the treatment of wet age-related macular degeneration (AMD), has been a major revenue generator for Regeneron and its development partner, Bayer. The original drug formulation, along with a higher dose version that received approval just last year, collectively brought in net sales of $5.89 billion in 2023, underscoring its blockbuster status.

The introduction of these biosimilars into the market is expected to provide more treatment options for patients while potentially reducing healthcare costs. Given the high sales figures of Eylea, the approval of Yesafili and Opuviz marks a significant development in the competitive landscape of ophthalmology treatments. The biosimilars are expected to provide comparable efficacy and safety to Eylea, thereby increasing accessibility for patients who require these critical treatments.

The approvals also highlight the increasing role of biosimilars in modern therapeutics, as companies aim to offer more affordable alternatives to existing high-cost treatments. The competitive dynamics introduced by the advent of biosimilars are anticipated to not only drive down costs but also foster innovation and improvements in the sector.

This development represents a significant achievement for both Biocon Biologics and Samsung Bioepis, expanding their footprint in the U.S. pharmaceutical market. It also underscores the FDA's ongoing efforts to enhance drug affordability and accessibility for patients by approving biosimilars that are interchangeable with established, high-cost medications.