Biogen and Samsung Obtain FDA Approval for Biosimilar to Roche’s Flagship Drug


Roche Lucentis’ flagship drug, a treatment for several eye disorders leading to vision loss, now has its first FDA approved biologically similar competitor, a product developed by a joint venture Biogen and Samsung BioLogics.

The regulatory decision means that the newly approved drug, named Byooviz, could soon be used as a cheaper alternative to Lucentis in the treatment of three eye disorders: the “wet” form of age-related macular degeneration (AMD); macular edema due to blockage of the veins in the retina; and myopic choroidal neovascularization, which is a complication of vision-threatening myopia.

Biologic drugs are derived from living organisms, and there is no way to make an exact copy of a cell or other biologic in the same way that a generic drug is a copy of a small one. molecule. Instead, a competing biologic drug is developed to be biologically similar or biosimilar.

Lucentis is an antibody that blocks vascular endothelial growth factor (VEGF), a signaling protein that promotes the growth of endothelial cells. This protein promotes the growth of blood vessels in the eye which are associated with several eye disorders. Roche’s drug, a chronic treatment given about once a month as an injection into the eye, generated more than 1.4 billion Swiss francs in revenue last year (about $ 1.5 billion) , an amount down 16% compared to 2019 sales. report of fourth quarter and full year financial results, the company attributed the decline in sales to the impact of Covid-19. Now the drug faces a looming competitive challenge from Byooviz.

Like Lucentis, Byooviz is also given as an ocular injection once a month. To gain FDA approval, the Biogen / Samsung Samsung Bioepis joint venture had to provide clinical data showing that its drug does not show any clinically meaningful difference in terms of safety and efficacy compared to Lucentis. U.S. regulatory approval makes Byooviz the first ophthalmic biosimilar approved in the United States, according to the FDA. The agency said it has approved 31 biosimilars to treat a variety of conditions. Byooviz’s move follows regulatory approvals for the therapy in the European Union and the UK last month.

Biogen, based in Cambridge, Mass., And Samsung BioLogics formed Samsung Bioepis in 2011, with Biogen as a minority shareholder holding approximately 5.4%. The joint venture made a small but growing contribution to Biogen sales. In 2020, Biogen reported $ 795.8 million in biosimilar revenue, an increase of over 7.7% from the previous year.

Two years ago, Biogen paid $ 700 million to Samsung BioLogics for increase your stake in the 49.9% joint venture, an agreement which also gave it exclusive rights to market Byooviz and another biosimilar candidate, SB15, in the United States, Canada, Europe, Japan and Australia. SB15 is a biosimilar that refers to Eylea, an eye medicine marketed by Regeneron Pharmaceuticals. Under an agreement between Samsung Bioepis and Genentech, a Roche subsidiary, Samsung Bioepis and Biogen could market Byooviz in the United States from June 2022, before Genentech’s patents for its drug expire. Byooviz can be marketed elsewhere after the patents expire.

Photo: Scott Eisen / Bloomberg, via Getty Images

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