FDA Approves First Ophthalmology Biosimilar for Neovascular Age-Related Macular Degeneration

The FDA has approved ranibizumab-nuna (Byooviz, Samsung Bioepis Co, Ltd), a biosimilar referencing ranibizumab (Lucentis, Biogen Inc), for the treatment of neovascular age-related macular degeneration (AMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

An anti-vascular endothelial growth factor therapy, ranibizumab prevents vision loss in patients with retinal vascular disorders, which can cause irreversible blindness or visual impairments in adults. Additionally, this is the first ophthalmology biosimilar approved in the United States, according to a press release.

"In the United States, approximately 11 million people are affected with AMD and the prevalence of advanced AMD is growing due to the aging population. The approval of the first ranibizumab biosimilar in the US is a monumental milestone for people living with retinal vascular disorders in the US," said Kyung-Ah Kim, senior vice president and development division leader at Samsung Bioepis, in a press release. “The approval of Byooviz underscores our continued commitment to providing valuable treatment options for people who do not have access to life-enhancing biologic medicines around the world.”

Further, ranibizumab-nuna was approved in Europe—which includes 27 European Union member countries—on August 18, 2021, and the UK on August 31, 2021.

The FDA’s approval was based on evidence that included analytical, non-clinical data, and clinical data, in which the efficacy, safety, pharmacokinetics, and immunogenicity were compared to reference ranibizumab in patients with wet AMD. The 705 patients were randomized to receive ranibizumab-nuna or reference ranibizumab in monthly injections, and 634 patients continued to receive treatment up to week 48.

The findings showed that the mean change in Least Squares (LS) for best corrected visual acuity (BCVA) from baseline at week 52 was 9.79 letters for SB11, compared with 10.41 letters for reference ranibizumab (difference: -0.62, [90% CI: -2.092, 0.857]). The LS mean change in central subfield thickness (CST) was −139.55 μm for SB11 vs −124.46 μm for the reference product (difference: -15.09, [95% CI, -25.617, -4.563]). Treatment-emergent adverse events and for the biosimilar and reference ranibizumab were comparable at all timepoints up to week 52, according to the study.

“This approval represents a great step toward the advancement of a new therapeutic option addressing debilitating disease progression of patients with retinal vascular disorders in the US,” said Ian Henshaw, senior vice president and global head of Biosimilars at Biogen, in a press release. “Biosimilars could help broaden patient access to more affordable treatments and generate health care savings to offset rising costs of these complex diseases while ensuring sustainability of health care systems.”

REFERENCE

FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna). Biogen. September 20, 2021. Accessed September 20, 2021. http://media.biogen.com/news-releases/news-release-details/fda-approves-samsung-bioepis-and-biogens-byooviztm-sb11