FDA approves first interchangeable biosims to Regeneron Eylea

21 May 2024
·
Deals
Drug Approval
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 AMDAMD, 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.
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Targets
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.