Positive phase III data for tocilizumab biosimilar presented at the Annual European Congress of Rheumatology (EULAR 2022).- Biogen + Bio-Thera Solutions Ltd.
Biogen Inc. and Bio-Thera Solutions, Ltd. presented positive Phase III data for BIIB 800 (BAT1806), a biosimilar candidate referencing Actemra/Roactemra (tocilizumab), anti-interleukin-6 receptor monoclonal antibody, at the Annual European Congress of Rheumatology (EULAR 2022).
Data from the Phase III comparative clinical trial demonstrated that the investigational biosimilar candidate BIIB 800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product. The double-blind 52-week Phase III study randomized 621 patients with moderate to severe rheumatoid arthritis to receive either BIIB 800 or the reference tocilizumab administered intravenously every 4 weeks at a dose of 8 mg/kg for the first 24 weeks. The primary endpoints were ACR20 response at week 12 and week 24. The ACR20 response rates in the BIIB 800 group and the reference tocilizumab group were 68.97% vs. 64.82% at week 12 and 69.89% vs. 67.94% at week 24. The estimated difference between the two groups were within the pre-defined equivalence margins (4.15% (95% CI - 3.63 to 11.93) at week 12 and 1.94% (90% CI -4.04 to 7.92; 95% CI -5.18 to 9.07) at week 24.
The treatment groups were comparable in terms of serum trough tocilizumab levels, incidence of treatment emergent adverse events and anti-drug antibody positivity and hence demonstrated comparable pharmacokinetics, safety and immunogenicity.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins