FDA Approves First Biosimilar to Treat Macular Degeneration

FDA recently approved Samsung Bioepis and Biogen’s Byooviz as the first biosimilar to Lucentis to treat several eye diseases and conditions. 

Byooviz is approved to treat neovascular (wet) age-related macular degeneration (nAMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

nAMD destroys the central vision needed to see clearly and is the leading cause of vision loss and blindness for Americans aged 65 years and older. In addition, myopic choroidal neovascularization is a vision-threatening complication of myopia. 

“The 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,” Sarah Yim, MD, director of the office of therapeutic biologics and biosimilars in the FDA’s Center for Drug Evaluation and Research, said in the announcement. 

“Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs,” Yim continued. 

There are two types of AMD, dry and wet. Dry AMD is more common, while wet AMD leads to vision loss at a faster rate. Macular edema and myopic choroidal neovascularization can lead to visual impairment as well. 

FDA based its approval of Byooviz on evidence that included structural and functional characterization, comparative clinical efficacy, and safety evaluations. 

In a Phase 3 trial, baseline age, best corrected visual acuity (BCVA), central subfield thickness (CST), and total lesion size were associated with the visual acuity and anatomical outcomes when managing nAMD with Byooviz or Lucentis. 

Overall, immunogenicity demonstrated that Byooviz is biosimilar to Lucentis.

So far, Byooviz was approved in Europe, including 27 European member countries and the UK. 
“We are very excited to be able to open a new chapter with the approval of Byooviz in the US. This approval represents a great step toward the advancement of a new therapeutic option addressing debilitating disease progression of patients with retinal vascular disorders,” Ian Henshaw, senior vice president and global head of biosimilars at Biogen, said in a statement.