Recent Biosimilar Approvals | Goodwin

On December 7, 2023, Bio-Thera Solutions, Ltd. announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN.  AVZIZI is the fifth bevacizumab biosimilar approved by the FDA, behind Amgen’s MVASI (bevacizumab-awwb), approved in September 2017; Pfizer’s ZIRABEV (bevacizumab-bvzr), approved in June 2019; Amneal’s ALYMSYS (bevacizumab-maly), approved in April 2022; and Celltrion’s VEGZELMA (bevacizumab-adcd), approved in September 2022.  According to Shengfeng Li, CEO at Bio-Thera, “The approval of Avzivi® is another landmark accomplishment for Bio-Thera as it marks Bio-Thera’s second FDA approved product in the United States.”  Bio-Thera previously received approval for its TOFIDENCE (tocilizumab-bavi) biosimilar in September 2023.

Also on December 7, 2023, Formycon AG, Polpharma Biologics Group BV, Bioeq AG, and Teva Canada Ltd. jointly announced that Health Canada has granted the “Notice of Compliance” (NOC) for FYB201/RANOPTO (ranibizumab), a biosimilar referencing Genentech’s LUCENTIS.  FYB201/RANOPTO was developed by Bioeq (a joint venture between Formycon and Polpharma), and in 2021, Teva entered into a strategic partnership for the exclusive commercialization of FYB201 in Canada, Europe, and selected other countries.  RANOPTO is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), and the treatment of visual impairment due to diabetic macular oedema (DME), choroidal neovascularization (CNV), and macular oedema secondary to retinal vein occlusion (RVO).

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