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News

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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