Skip to content Skip to footer
Subscribe Now
xbrane
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 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…
December 31, 2024

Read more

NEWS

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…
August 5, 2024

Read more