Biosimilars are equivalent to reference biologics in rheumatoid arthritis

As more patients with a variety of medical conditions are transitioned to biosimilar drugs, patients and healthcare providers may be asking whether biosimilars are comparable in efficacy and safety to the originator biologics. Biosimilars are lower-cost versions of originator biologics, providing cost-savings that could allow greater access to disease-modifying therapy in diseases such as rheumatoid arthritis (RA). However, there is a lack of adequate systematic reviews demonstrating therapeutic equivalence between biosimilars and their reference biologics in the treatment of RA. A new systematic review and meta-analysis was designed to assess the efficacy, safety and immunogenicity of biosimilars compared with their reference biologics in patients with RA. The review and meta-analysis assessed head-to-head randomized clinical trials of biosimilars of adalimumab, etanercept and infliximab and their biologic reference drugs when used for the treatment of RA. Equivalence (treatment success at six months) was tested using prespecified margins for the American College of Rheumatology criteria, with at least 20% improvement in the core set measures (ACR20) (i.e., relative risk [RR], 0.94–1.06), and for the Health Assessment Questionnaire–Disability Index (i.e., standardized mean difference [SMD], −0.22 to 0.22). Secondary outcomes included 14 items measuring safety and immunogenicity, including treatment-emergent adverse events, serious adverse events, special adverse events, mortality, discontinuation rates, positive antidrug antibody formation and positive neutralizing antibodies. Results showed the following: A total of 25 head-to-head trials were included, with data on 10,642 randomized patients with moderate to severe RA. All patients had experience with methotrexate. Overall, the most investigated biosimilars were for adalimumab (11 trials, 44%), etanercept and infliximab (7 trials [28%] each). At six months, biosimilars were equivalent to reference biologics in terms of ACR20 response (24 RCTs with 10,259 patients; RR, 1.01; 95% credibility intervals [CrI], 0.98–1.04) At six months, biosimilars were equivalent to reference biologics in terms of change of Health Assessment Questionnaire–Disability Index scores (14 RCTs with 5,579 patients; SMD, −0.04; 95% CrI, −0.11 to 0.02) Overall, biosimilars were associated with similar rates of adverse events, study discontinuation and immunogenicity responses compared with reference biologics. The authors note that to their knowledge, this is the largest systematic review to adequately examine the equivalence of biosimilars and reference biologics in RA. They conclude that their meta-analysis shows that biosimilars of adalimumab, infliximab and etanercept have clinically equivalent treatment effects compared with their reference biologics and are equally valuable in the treatment of RA. Reference 1. de Oliveira Ascef B, Almeida MO, de Medeiros-Ribeiro SAC, et al. Therapeutic equivalence of biosimilar and reference biologic drugs in rheumatoid arthritis. A systematic review and meta-analysis. JAMA Network Open 2023;6(5):e2315872. (accessed June 1, 2023).

Biosimilars are equivalent to reference biologics in rheumatoid arthritis

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