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: Alvotech and Advanz Pharma| Image: Alvotech and Advanz Pharma| Press Release
Related News:- Samsung Bioepis Report the CHMP’s Positive Opinion of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
