{"id":170,"date":"2016-11-02T03:50:52","date_gmt":"2016-11-02T03:50:52","guid":{"rendered":"https:\/\/white-family.or.jp\/wp\/?p=170"},"modified":"2020-06-15T03:59:12","modified_gmt":"2020-06-15T03:59:12","slug":"tnf-%ce%b1i%e3%81%ae%e3%83%90%e3%82%a4%e3%82%aa%e3%82%b7%e3%83%9f%e3%83%a9%e3%83%bc%e3%81%a7%e5%90%8c%e7%ad%89%e6%80%a7%e7%a2%ba%e8%aa%8d","status":"publish","type":"post","link":"https:\/\/white-family.or.jp\/wp\/?p=170","title":{"rendered":"TNF-\u03b1i\u306e\u30d0\u30a4\u30aa\u30b7\u30df\u30e9\u30fc\u3067\u540c\u7b49\u6027\u78ba\u8a8d"},"content":{"rendered":"

\u53c2\u8003\uff1aAnn Intern Med2016\u5e7411\u67082\u65e5 (\u6c34)\u914d\u4fe1<\/em><\/p>\n

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Chingcuanco F et al. Bioequivalence of Biosimilar Tumor Necrosis Factor-\u03b1 Inhibitors Compared With Their Reference Biologics: A Systematic Review. Ann Intern Med. 2016 Oct 18;165(8):565-574. doi: 10.7326\/M16-0428. Epub 2016 Aug 2.

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\u3010\u539f\u6587\u3092\u8aad\u3080\u3011
Annals of Internal Medicine<\/p>\n

<\/div>\n
Bioequivalence of Biosimilar Tumor Necrosis Factor-\u03b1 Inhibitors Compared With Their Reference Biologics: A Systematic Review

Francine Chingcuanco, MHS; Jodi B. Segal, MD, MPH; Seoyoung C. Kim, MD, ScD, MSCE; G. Caleb Alexander, MD
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Published: Ann Intern Med. 2016;165(8):565-574.
DOI: 10.7326\/M16-0428
Published at www.annals.org<\/a> on 2 August 2016
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2016 American College of Physicians
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Abstract

Background:
Biosimilars are of growing clinical, regulatory, and commercial importance.

Purpose:
To summarize evidence about the bioequivalence between biosimilar and reference tumor necrosis factor-\u03b1 (TNF-\u03b1) inhibitors.

Data Sources:
PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and LILACS from inception through 13 April 2016 and ClinicalTrials.gov<\/a>, World Health Organization International Clinical Trials Registry Platform, EU Clinical Trials Register, U.S. Food and Drug Administration, and European Medicines Agency from inception through 30 April 2016.

Study Selection:
Published English-language studies of any size or design that compared the pharmacokinetics, clinical efficacy, adverse events, or immunogenicity of a biosimilar TNF-\u03b1 inhibitor with a reference biologic in humans.

Data Extraction:
Two reviewers independently screened titles and abstracts, extracted data from selected studies, and assessed study quality.

Data Synthesis:
Of 19 eligible studies, 8 were phase 1 randomized trials, 5 were phase 3 randomized trials, and 6 were observational studies. Most phase 1 trials (n = 7) involved healthy volunteers, phase 3 trials involved patients with rheumatoid arthritis, and observational studies involved those with rheumatoid arthritis or inflammatory bowel disease. All phase 1 trials showed that pharmacokinetic parameters of the biosimilar and respective biologic were within the prespecified equivalence margin of 80% to 125%. Phase 3 trials suggested similar clinical responses and adverse events. Adverse events were usually of mild to moderate severity. Two cross-sectional observational studies showed cross-reactivity between products, whereas 4 cohort studies of patients switched from reference to biosimilar products suggested similar efficacy and safety outcomes.

Limitation:
Possible publication bias, small sample sizes of many studies, and lack of published studies for several biosimilars.

Conclusion:
Preliminary evidence supports the biosimilarity and interchangeability of biosimilar and reference TNF-\u03b1 inhibitors.

Primary Funding Source:
Johns Hopkins Center of Excellence in Regulatory Science and Innovation. (PROSPERO: CRD42015025262)<\/div>\n","protected":false},"excerpt":{"rendered":"

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