Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)
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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
