On 11 September 2024, Bio-Thera Solutions and Biogen published results from their phase 3 switching study for Tofidence™ (BAT1806/BIIB800), biosimilar to Roche’s Actemra®/RoActemra® (tocilizumab).
The study showed that comparable clinical efficacy, safety, immunogenicity and pharmacokinetics to Actemra®/RoActemra® is maintained after switching to Tofidence™ in patients with active rheumatoid arthritis.
Biogen acquired all exclusive rights for biosimilar tocilizumab BAT1806 from Bio-Thera in a deal announced in April 2021 for countries other than China.
BAT1806 was FDA-approved under the trade name Tofidence™ in September 2023, and was the second tocilizumab biosimilar approved in the EU for rheumatoid arthritis in June 2024 following the approval of Fresenius Kabi’s tocilizumab biosimilar, Tyenne® in September 2023.