First Biosimilar Approved for Neovascular Age-Related Macular Degeneration (nAMD)

FDA Approval

On September 17, 2021, the U.S. Food and Drug Administration (FDA) authorized Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration (nAMD). Byooviz was also approved to treat macular edema after retinal vein occlusion (RVO) and myopic choroidal neovascularization, a complication of myopia. Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, commented in a press release, “Today’s approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products.” ⁱ

Anti-vegf treatments

Byooviz, and its reference product Lucentis, are anti-vascular endothelial growth factor (anti-VEGF) treatments. Anti-VEGF therapies slow the growth of blood vessels in the eye, reducing or stopping damage from abnormal blood vessels and slowing down vision loss. Anti-VEGF therapies revolutionized the treatment of various chorioretinal disordersⁱⁱ, including nAMD, when they were first launched 15 years ago. However, anti-VEGFs require intravitreal injections approximately every four to six weeks or at most 8 weeks, creating considerable financial and frequent visit burden, which can be a factor in patient compliance.ⁱⁱⁱ Biosimilars such as Byooviz have the potential to considerably reduce the financial burden of anti-VEGF treatment.

Potential impact

Dr. Ronald Danis, a board-certified ophthalmologist with over 30 years of experience as a practicing medical retina specialist, as well as extensive involvement in the conduct and design of clinical trials said, “The first FDA approval of a biosimilar for Lucentis offers the promise of lower costs and greater accessibility for patients.” Dr. Danis continued, “For physicians who have been hesitant to recommend off-label bevacizumab, this represents a great new treatment option for nAMD.”

Looking to the future

While Byooviz is the first biosimilar for Lucentis to be approved, undoubtedly more biosimilars for anti-VEGF treatments are on the way.^iv A search as of November 17, 2021 on ClinicalTrials.gov for “neovascular AMD” and “biosimilar” shows 12 recruiting, active, or completed clinical trials including Bioeq’s FYB203 (Eylea), Samsung Bioepis’s SB15 (Eylea), Lupin’s LUBT010 (Lucentis), Sam Chun Dang’s SCD411 (Eylea), and Xbrane Biopharma’s Xlucane (Lucent).

Global clinical trials. These global clinical trials will provide further information about the safety and efficacy of biosimilars, as well as potential approvals for new treatment options for nAMD.

ABOUT nAMD

AMD is a common eye condition and a leading cause of vision loss among people aged 50 and older. It is a degenerative disease of the retina and is the most common retinal disease in the Western world.^v This disease is primarily broken into two subtypes, Dry AMD and nAMD; both lead to partial or complete loss of central vision. While less prevalent than dry AMD, nAMD accounts for almost 90% of blindness associated with the disease.