Alvotech and Advanz Pharma Reports the EMA’s MAA Acceptance of AVT05 (Biosimilar, Simponi)
Shots:
- The EMA has accepted the MAA of AVT05, biosimilar version of J&J's Simponi & Simponi Aria (golimumab), for the treatment of several chronic inflammatory diseases, with the decision expected in Q4’25
- Alvotech, in Apr 2024, reported top-line data from a confirmatory trial of AVT05 vs Simponi in patients with moderate to severe rheumatoid arthritis, showing similar efficacy, safety & immunogenicity. Earlier, in Nov 2023, it reported positive data from a PK trial among healthy adults which confirmed its tolerability & PK profile
- Golimumab is a monoclonal antibody that blocks TNF alpha, a protein involved in chronic inflammatory diseases like rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis
Ref: Teva | Image: Alvotech
Related News:- Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara)
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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.
