Bio-Thera and Biogen Release Phase 3 Data for TOFIDENCE™ Biosimilar in Arthritis Research & Therapy

Bio-Thera Solutions, Ltd., in collaboration with Biogen, has published results from a Phase 3 clinical study evaluating TOFIDENCE™ (BAT1806/BIIB800), a biosimilar to tocilizumab, in the journal Arthritis Research & Therapy. This study focused on patients with active rheumatoid arthritis (RA) who did not respond adequately to methotrexate. The study aimed to assess the efficacy, safety, immunogenicity, and pharmacokinetics of TOFIDENCE compared to reference tocilizumab over a 48-week period.

The Phase 3, multicenter, double-blind, active-controlled trial included participants randomized into three groups: one receiving intravenous tocilizumab (TCZ) every four weeks, another receiving TCZ for 24 weeks followed by TOFIDENCE for the next 24 weeks, and a third group administered TOFIDENCE throughout the 48 weeks. The study's primary measures of efficacy were American College of Rheumatology (ACR) response criteria (ACR20/50/70) and changes in the Disease Activity Score on 28 joints (DAS28). Secondary evaluations included pharmacokinetics, safety, and immunogenicity.

Results from weeks 24-48 of the study, referred to as Treatment Period 2 (TP2), demonstrated that switching from TCZ to TOFIDENCE maintained comparable clinical efficacy, safety, and immunogenicity. Proportions of ACR20 responders were similar across all groups at week 48, with 87.8% in the TCZ group, 90.3% in the TCZ to TOFIDENCE group, and 90.4% in the TOFIDENCE group. Additionally, the proportions of ACR50 and ACR70 responders and reductions in DAS28 scores were consistent among the groups. Drug trough levels and incidences of antidrug antibodies were also comparable. The safety profile was balanced across the groups, with no fatal events reported.

Dr. Xiaolei Yang, Executive Medical Director for Rheumatology and Immunology at Bio-Thera, emphasized that these findings support the long-term biosimilarity of TOFIDENCE to reference tocilizumab, addressing concerns over the safety and efficacy of switching treatments in clinical practice.

Bio-Thera Solutions and Biogen entered into a commercialization and license agreement on April 8th, 2021, granting Biogen exclusive rights to develop, manufacture, and commercialize TOFIDENCE in all countries excluding China, including Hong Kong, Macau, and Taiwan.

During the TP2 analysis, 577 out of 621 randomized participants completed the first 24 weeks of treatment and continued into the second period. This included 145 participants in the TCZ group, 142 in the TCZ to TOFIDENCE group, and 290 in the TOFIDENCE group. The longer-term findings from TP2 reinforced the initial results from the first 24 weeks of the study, further supporting the biosimilarity of TOFIDENCE to the reference product.

Bio-Thera Solutions, based in Guangzhou, China, focuses on developing novel therapeutics and biosimilars for treating cancer, autoimmune, cardiovascular, and other severe diseases. The company has four approved products, including TOFIDENCE, and over 20 candidates in clinical trials, emphasizing immuno-oncology and targeted therapies.

The findings from this study contribute significantly to the understanding of the long-term use of biosimilars in treating rheumatoid arthritis, providing valuable insights into their efficacy and safety when switching from reference biologics.

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