Biogen/Samsung Approval of BYOOVIZ™

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Samsung Bioepis, Co. Ltd. and Biogen Inc. announced yesterday that their biosimilar product BYOOVIZ™ (ranibizumab-nuna) was approved by FDA.  BYOOVIZ™ is a biosimilar to LUCENTIS®, which is indicated for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.  As Biogen noted, BYOOVIZ™ is the first ophthalmology biosimilar approved in the United States. Samsung Bioepis’ and Biogen’s ranibizumab biosimilar was previously approved in the EU on August 18, 2021, and in the United Kingdom on August 31, 2021.  As we previously reported, Samsung Bioepis and Biogen had entered into a commercialization agreement for two ophthalmology biosimilar candidates, ranibizumab and aflibercept, in November 2019.

Pursuant to a global license agreement entered into with Genentech, Samsung Bioepis and Biogen will have freedom to market BYOOVIZ™ in the United States as of June 2022, i.e., before expiration of Genentech’s applicable supplementary protection certificates (SPCs), and the same molecule in other territories after expiration of Genentech’s SPCs. Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen, noted with the company’s announcement of the BYOOVIZ™ approval that “[t]his approval represents a great step toward the advancement of a new therapeutic option addressing debilitating disease progression of patients with retinal vascular disorders in the U.S.” and that “[b]iosimilars could help broaden patient access to more affordable treatments and generate healthcare savings to offset rising costs of these complex diseases while ensuring sustainability of healthcare systems.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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