Shots:
- The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25
- Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr 2024 & topline results from a PK study comparing AVT05 & Simponi among healthy adults in Nov 2023
- Additionally, Alvotech partnered with Teva in Aug 2020 to market five biosimilars, incl. AVT05, in the US. Later, the partnership expanded to nine products in total
Ref: Globenewswire | Image: Alvotech & Teva
Related News:- Alvotech and Advanz Pharma Reports the EMA’s MAA Acceptance of AVT05 (Biosimilar, Simponi)
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