Shots:
The P-III study evaluates BIIB800 (q4w, IV, at a dose of 8mg/kg for the first 24wks.) vs Actemra/Roactemra in 621 patients with moderate to severe RA with inadequate response to methotrexate
The results showed that biosimilar BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to tocilizumab, ACR20 response rates (68.97% vs 64.82%) @12wk. & (69.89% vs 67.94%) @24wk., estimated difference b/w two groups were within the pre-defined equivalence margins (4.15% & 1.94%) @12 & 24wk.
The treatment groups showed equivalent PK, safety, and immunogenicity in terms of serum trough tocilizumab levels, the incidence of treatment-emergent AEs, and anti-drug Ab positivity
Ref: Biogen Image: Biogen
