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Biogen, Bio-Thera Presents Positive Phase 3 Data For Tocilizumab Biosimilar In Rheumatoid Arthritis

At the Annual European Congress of Rheumatology on Friday, biotechnology companies Biogen Inc. (BIIB) and Bio-Thera Solutions, Ltd. presented positive Phase 3 data for BIIB800 (BAT1806), a biosimilar candidate referencing ACTEMRA/ROACTEMRA (tocilizumab), anti-interleukin-6 receptor monoclonal antibody.

Data from the Phase 3 comparative clinical trial demonstrated that the investigational biosimilar candidate BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product.

The double-blind 52-week Phase 3 study randomized 621 patients with moderate to severe rheumatoid arthritis to receive either BIIB800 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 BIIB800 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 differences between the two groups were within the pre-defined equivalence margins at week 12 and 1.94% at week 24.

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