The company initiates the P-II confirmatory patient study of AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab) evaluating the efficacy, safety, and immunogenicity of AVT05 (SC) vs EU-approved Simponi in adult patients with mod. to sev. rheumatoid arthritis
The primary outcome measures will be to show the comparative efficacy of AVT05 vs Simponi @16wks. based on change from baseline on a standardized DAS28-CRP which evaluates the severity of RA using clinical and laboratory data
Additionally, the company initiates PK study for AVT05 in Jan 2023. Golimumab is a mAb that inhibits tumor necrosis factor-alpha (TNF alpha)
Ref: GlobeNewswire | Image: Alvotech
Related News:- Alvotech Reports Initiation of Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi and Simponi Aria
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