US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced that they have received marketing approval from the European Commission (EC) for their Opuviz 40 mg/mL solution for injection in a vial. This biosimilar product, a version of Bayer/Regeneron’s Eylea (aflibercept), is now approved for use in treating adult patients with various vision impairments, including neovascular (wet) age-related macular degeneration (AMD), macular oedema secondary to retinal vein occlusion (RVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (myopic CNV).
Samsung Bioepis’ Transition and Partnership with Biogen
Samsung Bioepis, initially a joint venture between Biogen and Samsung Biologics (KRX: 207940) established in 2012, became a wholly owned subsidiary of the South Korean firm in 2022. This transition occurred when Samsung Biologics acquired Biogen’s remaining shares in the company for USD 2.3 billion. The partnership between Samsung Bioepis and Biogen dates back to November 2019, with Biogen being granted commercialization rights to BYOOVIZ, a biosimilar of Novartis’s Lucentis (ranibizumab), and Opuviz, also known as SB15 in the US, Canada, Europe, and other certain countries.
Opuviz’s Approval in a Competitive Landscape
Opuviz’s regulatory approval follows closely on the heels of the EC’s approval of Switzerland-headquartered Sandoz’s (SWX: SDZ) Afqlir, issued earlier this week. This marks a significant development in the competitive landscape of biosimilars for ophthalmic treatments in Europe.-Fineline Info & Tech
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