Shots:
- The US FDA has issued a CRL related to the BLA for AVT05, a biosimilar version of Simponi (golimumab), in PFS & autoinjector formulations
- The CRL noted certain deficiencies from the FDA’s Jul 2025 pre-license inspection of Alvotech’s Reykjavik facility that must be resolved before AVT05 BLA approval, though no other issues were found, and the site remains FDA-approved & operational
- Simponi is an IgG1 monoclonal antibody that targets TNF-alpha, resulting in the decrease of inflammatory markers like CRP, IL-6, ICAM-1, MMP-3, & VEGF for treating chronic inflammatory & immune-mediated diseases
Ref: Alvotech | Image: Alvotech | Press Release
Related News:- Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)
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