Authors from Japan provide a new perspective on biosimilars for management of rheumatoid arthritis (RA) to provide evidence of efficacy and safety of biosimilars compared with reference biological disease-modifying anti-rheumatic drugs (bDMARDs) (reference bDMARDs) in patients with RA as a part of the process of developing the 2020 update of the Japan College of Rheumatology (JCR) guidelines for the management of RA .
Increasing costs for treating RA, including expensive bDMARDs, have become an important issue not only for patients but also for societies. The cost of biosimilars is approximately 60% that of the reference bDMARDs. Therefore, the widespread use of biosimilars can be expected to be more cost-effective and useful considering the reduction of the economic burden for society and the patient.
The systematic review carried out by Tanaka et al. included 20 randomized controlled trials using biosimilars of infliximab, etanercept and adalimumab. A meta-analysis revealed that the risk ratios (RRs) and 95% confidence intervals (CIs) of achieving the American College of Rheumatology 50% response (ACR50) at Week 24 and serious adverse events (SAEs) for biosimilars compared with the reference bDMARDs were 1.04 (0.98–1.10) and 0.84 (0.61–1.18), respectively. The RRs of achieving ACR50 and SAEs at Week 24 were respectively 0.93 (0.69–1.26) and 2.15 (0.55–8.35) in the patients who switched to biosimilars from the reference bDMARDs and 0.92 (0.76–1.12) and 1.41 (0.32–6.15) in those who continued the reference bDMARDs.
The results indicated that both biosimilars and reference bDMARDs were equally useful for patients with RA. Introduction of biosimilars had equivalent efficacy and safety to reference bDMARDs in RA patients with high or moderate disease activity who had insufficient responses to conventional synthetic (cs)DMARDs (traditional drugs, such as methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold salts). In addition, switching to biosimilars was equally useful in RA patients treated with reference bDMARDs compared to maintaining bDMARDs (continuing reference bDMARDs or continuing biosimilars).
The authors noted that there is no Cochrane review on biosimilars in patients with RA. Therefore, they concluded that this study is the first comprehensive meta-analysis investigating whether biosimilars can be used in the same way as reference bDMARDs in patients with active RA who are refractory to treatment with csDMARDs.
Conflict of interest
The authors of the research paper  reported conflict of interest, including having received lecture fees, consulting fees, research grants, speaker fees and honoraria from pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper .
Abstracted by Dr Eiichi Tanaka, Associate Professor, Division of Rheumatology, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine and Institute of Rheumatology, Tokyo Women’s Medical University Hospital, Tokyo, Japan.
Readers interested to learn more about biosimilars in Japan are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Biosimilar development and regulation in Japan
Japan proving to be a favourable market for biosimilars
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1. Tanaka E, Kawahito Y, Kohno M, et al. Systematic review and meta-analysis of biosimilar for the treatment of rheumatoid arthritis informing the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis. Mod Rheumatol. 2021 Apr 6:1-13.
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