FDA Approves First Biosimilar to Treat Macular Degeneration


Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.

The FDA has approved Biogen and Samsung Bioepis’ Byooviz (ranibizumab-nuna) as the first biosimilar to Genentech’s Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration, a leading cause of vision loss and blindness for Americans over the age of 65. Byooviz is also approved to treat macular edema following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness).

Byooviz is an anti-vascular endothelial growth factor (VEGF) therapy that prevents vision loss in patients with retinal vascular disorders, which can cause irreversible blindness or visual impairments in adults in the United States.

The FDA approval of Byooviz was based on a totality of evidence including analytical, nonclinical data, and clinical data. In a phase 3 study, the efficacy, safety, pharmacokinetics, and immunogenicity of Byooviz was compared with Lucentis in patients with wet AMD.

Sarah Yim, M.D.

Sarah Yim, M.D.

“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,” Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, said in a statement.

There are two types of AMD—dry and wet. While dry AMD is more common, wet AMD leads to vision loss at a faster rate. Both macular edema and myopic choroidal neovascularization can also lead to visual impairment. About 11 million people are affected with AMD in the United States alone, with a global prevalence of 170 million.

Byooviz was approved in the European Union (EU) on August 18, 2021, and the United Kingdom on August 31, 2021.

BYOOVIZ is Samsung Bioepis’ fifth biosimilar approved in the United States, following the approval of Renflexis (infliximab-abda), a biosimilar of Remicade approved in April 2017 to treat several autoimmune diseases including Crohn’s and rheumatoid, Ontruzant (trastuzumab-dttb), a biosimilar of Herceptin approved in January 2019 to treat HER2-positive breast and gastric cancer, Eticovo (etanercept-ykro), a biosimilar of Enbrel approved in April 2019 to treat arthritis and plaque psoriasis, and Hadlima (adalimumab-bwwd), a biosimilar of Humira approved in July 2019 to treat arthritis and psoriasis.

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