The clinical Phase III study results of the BIO-THERA Tocilizumab biosimilar, TOFIDENCE™ (BAT1806/BIIB800), have been published in the prestigious international rheumatology journal, The Lancet Rheumatology (impact factor IF = 25.4).

This research, derived from a global multicenter, randomized, double-blind, active-controlled Phase III clinical study (ClinicalTrials.gov, NCT03830203; EudraCT, 2018-002202-31), reveals outcomes from the initial treatment phase (TP1). The study, conducted in 54 centers across five countries (China, Ukraine, Poland, Georgia, Bulgaria), included a 24-week initial treatment phase (TP1) followed by a subsequent 24-week secondary treatment phase (TP2).

A total of 621 patients with moderate to severe rheumatoid arthritis, unresponsive to methotrexate, were enrolled. During the trial, participants received investigational drug therapy with an initial dose of 8mg/kg, administered intravenously every four weeks, either BAT1806/BIIB800 or the reference Tocilizumab. The study consisted of two treatment stages (TP1 and TP2), with 50% of the control group transitioning to BAT1806/BIIB800 treatment in TP2 until week 48. The primary endpoint was the proportion of patients achieving ACR20 at either week 12 (European Medicines Agency requirement) or week 24 (U.S. Food and Drug Administration and China National Medical Products Administration requirements). Clinical equivalence was calculated using pre-specified equivalence ranges (EMA: 95% CI -14.5% to +14.5%; FDA: 90% CI -12.0% to +15.0%; NMPA: 95% CI -13.6% to +13.6%), following the International Council for Harmonisation (ICH) E9 (R1) guidance and strategies for handling adverse events.

The TP1 results, as reported in The Lancet Rheumatology, demonstrate the equivalence of BAT1806/BIIB800 to the reference Tocilizumab in terms of efficacy. Additionally, the international multicenter clinical study observes comparable safety, immunogenicity, and pharmacokinetics between BAT1806/BIIB800 and the reference Tocilizumab. Publication of the relevant results from the TP2 phase is currently underway.

This study provides substantial evidence that the Tocilizumab biosimilar BAT1806/BIIB800 is comparable to the reference Tocilizumab in terms of efficacy, safety, immunogenicity, and pharmacokinetic characteristics in patients with active rheumatoid arthritis inadequately responsive to methotrexate. This evidence is pivotal for the drug's regulatory approval and market entry in both domestic and international regions.

TOFIDENCE™ (BAT1806/BIIB800) is the first Tocilizumab biosimilar approved by the China National Medical Products Administration (NMPA) and the first monoclonal antibody drug developed, produced, and approved by the U.S. FDA from a Chinese local pharmaceutical company.

https://mp.weixin.qq.com/s/2vvliBgrsxdEP7FQrtGoVw