Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: Results from the phase III randomised VOLTAIRE-RA equivalence study
Annals of Rheumatic Diseases Mar 15, 2018
Cohen SB, et al. - Authors conducted this study to demonstrate the efficacy, safety, and immunogenicity [antidrug antibodies (ADAs), ADA titres and neutralizing antibodies] of adalimumab biosimilar candidate BI 695501 with Humira in subjects with moderately to severely active rheumatoid arthritis. They found that BI 695501 vs Humira had similar efficacy, safety, and immunogenicity. No effect on the efficacy, safety, and immunogenicity was noted after switching from Humira to BI 695501.
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