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Biogen and Bio-Thera Solutions Present Results of BIIB800 (biosimilar, tocilizumab) in P-III Trial for Rheumatoid Arthritis at EULAR 2022

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Biogen and Bio-Thera Solutions Present Results of BIIB800 (biosimilar, tocilizumab) in P-III Trial for Rheumatoid Arthritis at EULAR 2022

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  • 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

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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