FDA approves first ophthalmology biosimilar drug

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The FDA has approved a ranibizumab biosimilar, its first ophthalmologic biosimilar, according to a Sept. 20 report from the Center for Biosimilars.

A biosimilar to Genentech's Lucentis, Byooviz can be used to treat adults with neovascular age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.

Byooviz will not be available until at least June because of a licensing agreement between its developer, South Korean-based Samsung Bioepis, and Genentech. It will be marketed by Cambridge, Mass.-based biotechnology company Biogen.

Kyung-Ah Kim, Samsung Bioepis' senior vice president and development division leader, said Biogen and Samsung Bioepis intend to create an education program for eye care specialists to develop interest in using Byooviz.

The anticipated cost of Byooviz was not disclosed.

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