Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate
Shots:
- Xbrane Biopharma has resubmitted the BLA for its biosimilar of Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024
- The CRL stated requirement of 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 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
Related News:- Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
