The first ranibizumab biosimilar (Byooviz) has potential to alleviate financial burden associated with retinal conditions, but may not be the only new approval for ophthalmology treatment in 2022, explains Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars for Cardinal Health.
Cardinal Health is a multinational health care services company that specializes in the distribution of pharmaceuticals and medical products. The Center for Biosimilars® spoke with Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars for Cardinal Health, about the FDA’s recent approval of the ranibizumab biosimilar Byooviz, a product developed by Samsung Bioepis and slated for commercialization by Biogen.
Marketing of this product is not expected to commence before June 2022, but Samsung Bioepis and Biogen hope to use that time to build awareness of the product and lay the groundwork for strong acceptance of what will be the first ranibizumab biosimilar in the United States and possibly elsewhere, too.
In this interview, Oskouei, who is also an Advisory Board member for The Center for Biosimilars®, discusses the strong need for affordable treatment options in the ophthalmology space and the value proposition that Byooviz brings to the table. The originator ranibizumab, Lucentis, is many times more costly than bevacizumab (Avastin), another anti–vascular endothelial growth factor (VEGF) treatment option that has a long history of success in treatment of potentially blinding eye disease.
The big question is the discount from originator price that will accompany this biosimilar launch and what rationale eye disease specialists will use in deciding when to use this product, Oskouei explains.
Also important to consider, she says, is that biosimilars are newcomers in the ophthalmology space, and many stakeholders will be facing the choice of biosimilars for the first time. “I think that’s going to be a key part of how this product and other ophthalmology biosimilars perform in the market,” she says.
The timing of launch, which depends on a licensing agreement between Samsung Bioepis, Biogen, and the originator company, Genentech, offers a window during which novel treatment compounds may enter the picture, potentially adding to the complex dynamics that will affect the market reception for Byooviz, she adds.
As part of its coverage of this event, The Center for Biosimilars® also spoke with George Williams, MD, clinical spokesperson for the American Academy of Ophthalmology. In addition, a text story about the FDA approval is also available.