FDA Approves Yet Another Interchangeable Biosimilar and Another Biosimilar | McDonnell Boehnen Hulbert & Berghoff LLP
On October 3, 2023, the U.S. Food and Drug Administration (FDA) announced approval of Biogen’s Byooviz (ranibizumab-nuna) as an interchangeable biosimilar to Genentech’s Lucentis (ranibizumab injection). The drug was approved for intravitreal injection for the following indications:
• Neovascular (Wet) Age-Related Macular Degeneration (AMD),
• Macular Edema Following Retinal Vein Occlusion (RVO), and
• Myopic Choroidal Neovascularization (mCNV).
Byooviz and Lucentis share administration route, dose (0.5 mg), and formulation (10 mg/mL). Byooviz had been previously approved as a biosimilar on September 20, 2021.
On December 6, 2023, the FDA approved Bio-Thera Solution’s Avzivi (bevacizumab-tnjn) as a biosimilar to Genentech’s Avastin (bevacizumab). This drug was approved for treatment of colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The biosimilar is available as 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL (25 mg/mL) injections in a single-dose vial.
These approvals bring to 45 the number of approved biosimilar products of which seven are interchangeable.
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