USA – Biogen Inc together with Samsung Bioepis Company Limited have announced that the USFDA has granted their neovascular age-related macular degeneration (wet AMD) drug, Ranibizumab, approval for use against macular edema.

This drug will be in competition with Lucentis, Roche’s blockbuster drug which was approved in 2006 and has accumulated sales of over US$1.61 billion in U.S. this past year.

FDA’s approval is another win for Biogen, which in the recent months has been hitting headlines due to its controversial yet trendsetting Alzheimer’s drug Aduhelm.

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

According to Hopkins medicine, age-related macular degeneration is the most common cause of severe loss of eyesight among people 50 and older in the United States.

Developed by Samsung Bioepis, Ranibizumab marks the first ophthalmology biosimilar approved in the United States.

Kyung-Ah Kim, Senior Vice President, and Development Division Leader, at Samsung Bioepis said:

Approximately 11 million people are affected with AMD and the prevalence of advanced AMD is growing due to the aging population in the U.S.

“The approval of the first ranibizumab biosimilar in the U.S. is a monumental milestone for people living with retinal vascular disorders in the U.S.”

The drug will be commercialized under the brand name Byooviz by Biogen in the United States and is set to debut next year under a licensing deal between the two biopharmaceutical companies.

Byooviz will be an essential addition to Biogen’s biosim outfit, which generated US$796 million last year.

The drug’s launch will come at a critical time for the biopharma as it works to gain traction with Aduhelm, rolled out for Alzheimer’s disease treatment.

Its big-selling spinal muscular atrophy drug, Spinraza, faces new oral competition from Roche Gantenerumab.

Meanwhile, SB15, biosims equivalent of Regeneron’s market-leading eye drug Eylea, continues to advance through development.

Eylea generated US$4.95 billion in the U.S. last year, so it’s a larger target for generic manufacturers. Eylea biosims could debut in 2023, analysts’ figure.

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