Shots:
- Xbrane Biopharma has resubmitted the BLA for its biosimilar product, referencing Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024
- The CRL stated requirement for additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing follow-up actions with its manufacturing partners
- Ranibizumab is an anti-VEGF drug indicated for treating wet AMD, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) & myopic choroidal neovascularization (mCNV)
Ref: Xbrane Biopharma| Image: Xbrane Biopharma| Press Release
Related News:- Xbrane Entered into an Agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) and Parts of its Organization for ~$27.25M
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