{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T16:24:26Z","timestamp":1783441466261,"version":"3.54.6"},"reference-count":32,"publisher":"S. Karger AG","license":[{"start":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T00:00:00Z","timestamp":1778198400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T00:00:00Z","timestamp":1778198400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacology"],"abstract":"<jats:p>Introduction: The aim of the study was to systematically evaluate the efficacy, safety, immunogenicity, and pharmacokinetics (PK) of tocilizumab biosimilars compared to reference tocilizumab (r-TCZ) in patients with rheumatoid arthritis (RA) and healthy volunteers. Methods: We searched PubMed, Embase, and Cochrane CENTRAL for phase I and III randomized controlled trials (RCTs) comparing tocilizumab biosimilars vs. r-TCZ. Primary outcomes included change from baseline in DAS28-ESR, ACR20\/50\/70 response rates, adverse events (AEs), serious AEs (SAEs), anti-drug antibody (ADA) positivity, and PK parameters (AUC&lt;sub&gt;0\u2212inf&lt;\/sub&gt;, C&lt;sub&gt;max&lt;\/sub&gt;, and AUC&lt;sub&gt;0\u2212last&lt;\/sub&gt;). Random-effects meta-analyses were performed using mean difference (MD), risk ratio (RR), and geometric mean ratio (GMR) with 95% or 90% confidence intervals (CIs). This systematic review and meta-analysis have been registered in PROSPERO (CRD420251270353). Results: Eight studies met the inclusion criteria, comprising 3 phase III RCTs (n = 1,696 RA patients) and 5 phase I RCTs (n = 1,363 healthy volunteers), for a total of 3,059 participants. In RA patients, biosimilars demonstrated equivalent efficacy to r-TCZ at week 24, with no significant differences in DAS28-ESR change (MD \u22120.06; 95% CI: \u22120.19 to 0.06; I2 = 0%) or ACR20 response rates (RR 1.03; 95% CI: 0.96\u20131.10; I2 = 0). Results for ACR50 and ACR70 were similarly balanced. Safety profiles were comparable (any AE: RR 1.01; 95% CI: 0.94\u20131.08), as was immunogenicity (ADA positivity: RR 1.28; 95% CI: 0.99\u20131.65). In healthy volunteers, PK biosimilarity was confirmed across intravenous and subcutaneous routes with pooled GMRs (90% CI) of 104.5% (101.2\u2013107.9%) for AUC&lt;sub&gt;0\u2212inf&lt;\/sub&gt;, 101.4% (98.5\u2013104.4%) for C&lt;sub&gt;max&lt;\/sub&gt;, and 102.3% (97.8\u2013106.9%) for AUC&lt;sub&gt;0\u2212last&lt;\/sub&gt;; all pooled CIs lay entirely within the 80\u2013125% regulatory acceptance range (I2 \u2264 35). Conclusion: Tocilizumab biosimilars exhibit therapeutic similarity in RA patients and pharmacokinetic biosimilarity in healthy volunteers compared to r-TCZ, with comparable safety and immunogenicity, supporting their use as credible, cost-effective alternatives in clinical practice.<\/jats:p>","DOI":"10.1159\/000552447","type":"journal-article","created":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T16:01:09Z","timestamp":1778256069000},"page":"1-14","source":"Crossref","is-referenced-by-count":0,"title":["Tocilizumab Biosimilars versus Reference Tocilizumab in Rheumatoid Arthritis: A Meta-Analysis of Pharmacokinetic Biosimilarity, Efficacy, Safety, and Immunogenicity"],"prefix":"10.1159","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4213-1909","authenticated-orcid":false,"given":"Young Ho","family":"Lee","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gwan Gyu","family":"Song","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2026,5,8]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2024.0151"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2024.0072"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-023-00634-1"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2024.0130"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.3109\/08830185.2014.938325"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2024.0133"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2024.0026"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2024.0073"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2025.0039"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2021.11.009"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1007\/s11096-024-01825-8"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.12659\/msm.934475"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780390105"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1007\/bf01068419"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2005.06.006"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1136\/bmjebm-2022-112102"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2017.05.006"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.3904\/kjim.2016.195"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.1037\/1082-989x.11.2.193"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2024.0095"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.4078\/jrd.2024.0103"},{"key":"ref22","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2024-004514"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.1136\/rmdopen-2023-003596"},{"key":"ref24","doi-asserted-by":"publisher","DOI":"10.1080\/1744666x.2023.2174104"},{"key":"ref25","doi-asserted-by":"publisher","DOI":"10.1080\/1744666x.2022.2060204"},{"key":"ref26","doi-asserted-by":"publisher","DOI":"10.1080\/13543784.2023.2212155"},{"key":"ref27","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2020.609522"},{"key":"ref28","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2024-eular.209"},{"key":"ref29","doi-asserted-by":"publisher","DOI":"10.1016\/s2665-9913(23)00237-0"},{"key":"ref30","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-022-00533-x"},{"key":"ref31","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-210297"},{"key":"ref32","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.15872"}],"container-title":["Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/article-pdf\/doi\/10.1159\/000552447","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T16:02:42Z","timestamp":1783440162000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000552447"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,8]]},"references-count":32,"URL":"https:\/\/doi.org\/10.1159\/000552447","archive":["Portico"],"relation":{"is-supplemented-by":[{"id-type":"doi","id":"10.6084\/m9.figshare.32200566","asserted-by":"subject"}]},"ISSN":["0031-7012","1423-0313"],"issn-type":[{"value":"0031-7012","type":"print"},{"value":"1423-0313","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,8]]}}}