Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX

Phase 3 Completed 502 enrolled Alvotech Swiss AG

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a study to compare the efficacy, safety and immunogenicity of AVT05 versus EU-Simponi® in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA). The study will consist of up to 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-up Period.

Timeline

Start: 2023-03-30
Primary completion: 2024-03-04
Completion: 2024-09-24

Outcome

Met primary endpoint

paper was entirely contained within the prespecified equivalence margin of - 0.6, 0.6 PMID 41182658 ↗

release “The confirmatory clinical safety and efficacy study for AVT05, biosimilar candidate to Simponi® and Simponi Aria® (golimumab), met its primary endpoint” alvotech.com ↗

Publications

Luque M, Zhelyazkova K, Vashishta L, Rai M, Sattar A, Petrovic K, Bucknall R, Leutz S, Berti F. Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study. BioDrugs. 2026 Jan;40(1):135-149. doi: 10.1007/s40259-025-00748-8. Epub 2025 Nov 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AVT05	Monoclonal antibody	50 mg	Subcutaneous
Comparator	Golimumab	Monoclonal antibody	50 mg	Subcutaneous