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.