Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate

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…

ByDipanshu DixitDecember 31, 2024

Lupin Reports the P-III Study Completion of LUBT010 (Biosimilar, Lucentis) for Neovascular Age-related Macular Degeneration

Shots: Lupin has concluded P-III study evaluating the efficacy, safety & immunogenicity of LUBT010 (0.5mg, intravitreal, QM for 1yr.) vs Lucentis in wet AMD adults (n=600) across India, US, EU & Russia The trial met its 1EP, showing therapeutic equivalence in visual acuity improvement plus similarity in safety & immunogenicity b/w both the drugs. Results will…

ByDipanshu DixitAugust 5, 2024

Xbrane Biopharma and STADA Team Up with Valorum Biologics for Commercializing Xlucane (Biosimilar, Ranibizumab) Across the US

Shots: Xbrane & STADA have signed an exclusive license agreement with Valorum Biologics to commercialize Xlucane, biosimilar of ranibizumab, across the US As per the agreement, both companies will complete the regulatory approval process; Xbrane to handle commercial manufacturing & supply. Post approval, Valorum will take care of sales, marketing & other commercial activities of…

ByDipanshu DixitMay 10, 2024

Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate

Xbrane Biopharma and STADA Team Up with Valorum Biologics for Commercializing Xlucane (Biosimilar, Ranibizumab) Across the US

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