BioPharma, Pharma

Biogen and Samsung land FDA approval for biosimilar to blockbuster Roche drug

The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat three eye conditions that lead to vision loss.


Blockbuster Roche drug Lucentis, a therapy for several eye disorders that lead to vision loss, now has its first FDA-approved biologically similar competitor, a product developed by a Biogen and Samsung BioLogics joint venture.

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

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

Lucentis is an antibody drug that blocks vascular endothelial growth factor (VEGF), a signaling protein that promotes endothelial cell growth. This protein promotes the growth of blood vessels in the eye that are associated with several eye disorders. The Roche 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), a sum that was a 16% decline compared to sales in 2019. In its report of fourth quarter and full year financial results, the company attributed the sales drop to the impact of Covid-19. Now the drug faces a looming competitive challenge from Byooviz.

Like Lucentis, Byooviz is also given as a once-a-month eye injection. To win FDA approval, the Biogen/Samsung joint venture Samsung Bioepis needed to provide clinical data showing that its drug has no clinically meaningful differences in safety and effectiveness compared to Lucentis. The U.S. regulatory nod makes Byooviz the first ophthalmology biosimilar approved in the U.S., according to the FDA. The agency said it has approved 31 biosimilars addressing a variety of conditions. The decision for Byooviz follows regulatory approvals of the therapy in the European Union and the U.K. last month.

Cambridge, Massachusetts-based Biogen and Samsung BioLogics formed Samsung Bioepis in 2011, with Biogen as the minority shareholder owning about 5.4%. The joint venture has been a small but growing contributor to Biogen’s sales. In 2020, Biogen reported $795.8 million in biosimilar product revenue, a more than 7.7% increase over the prior year.

Two years ago, Biogen paid Samsung BioLogics $700 million to boost its stake in the joint venture to 49.9%, a deal that also gave it the exclusive rights to commercialize Byooviz and another biosimilar candidate, SB15, in the U.S., Canada, Europe, Japan, and Australia. SB15 is a biosimilar that references Eylea, an eye drug marketed by Regeneron Pharmaceuticals. Under an agreement that Samsung Bioepis reached with Roche subsidiary Genentech, Samsung Bioepis and Biogen may market Byooviz in the U.S. starting in June 2022, before Genentech’s patents for its drug expire. Byooviz may be marketed elsewhere after the patents expire.

Photo: Scott Eisen/Bloomberg, via Getty Images