Matches in SemOpenAlex for { <https://semopenalex.org/work/W2480851940> ?p ?o ?g. }
- W2480851940 endingPage "565" @default.
- W2480851940 startingPage "565" @default.
- W2480851940 abstract "Biosimilars are of growing clinical, regulatory, and commercial importance.To summarize evidence about the bioequivalence between biosimilar and reference tumor necrosis factor-α (TNF-α) inhibitors.PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and LILACS from inception through 13 April 2016 and ClinicalTrials.gov, 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.Published English-language studies of any size or design that compared the pharmacokinetics, clinical efficacy, adverse events, or immunogenicity of a biosimilar TNF-α inhibitor with a reference biologic in humans.Two reviewers independently screened titles and abstracts, extracted data from selected studies, and assessed study quality.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.Possible publication bias, small sample sizes of many studies, and lack of published studies for several biosimilars.Preliminary evidence supports the biosimilarity and interchangeability of biosimilar and reference TNF-α inhibitors.Johns Hopkins Center of Excellence in Regulatory Science and Innovation. (PROSPERO: CRD42015025262)." @default.
- W2480851940 created "2016-08-23" @default.
- W2480851940 creator A5005567441 @default.
- W2480851940 creator A5008078906 @default.
- W2480851940 creator A5010621055 @default.
- W2480851940 creator A5071878173 @default.
- W2480851940 date "2016-08-02" @default.
- W2480851940 modified "2023-09-30" @default.
- W2480851940 title "Bioequivalence of Biosimilar Tumor Necrosis Factor-α Inhibitors Compared With Their Reference Biologics" @default.
- W2480851940 cites W1147832057 @default.
- W2480851940 cites W1827882046 @default.
- W2480851940 cites W1851453522 @default.
- W2480851940 cites W1927365763 @default.
- W2480851940 cites W1954244899 @default.
- W2480851940 cites W2004375912 @default.
- W2480851940 cites W2022888597 @default.
- W2480851940 cites W2028465542 @default.
- W2480851940 cites W2073521094 @default.
- W2480851940 cites W2098923148 @default.
- W2480851940 cites W2106152050 @default.
- W2480851940 cites W2118596556 @default.
- W2480851940 cites W2119740605 @default.
- W2480851940 cites W2121050884 @default.
- W2480851940 cites W2128376479 @default.
- W2480851940 cites W2130202488 @default.
- W2480851940 cites W2137961216 @default.
- W2480851940 cites W2139366207 @default.
- W2480851940 cites W2148487286 @default.
- W2480851940 cites W2162768160 @default.
- W2480851940 cites W2171098916 @default.
- W2480851940 cites W2174460595 @default.
- W2480851940 cites W2203977709 @default.
- W2480851940 cites W2259088801 @default.
- W2480851940 cites W2293557195 @default.
- W2480851940 cites W2293707540 @default.
- W2480851940 cites W2296528535 @default.
- W2480851940 cites W2314763045 @default.
- W2480851940 cites W2317502128 @default.
- W2480851940 cites W2324319956 @default.
- W2480851940 cites W2342464058 @default.
- W2480851940 cites W2345220764 @default.
- W2480851940 cites W2397773641 @default.
- W2480851940 cites W798616579 @default.
- W2480851940 doi "https://doi.org/10.7326/m16-0428" @default.
- W2480851940 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/27479870" @default.
- W2480851940 hasPublicationYear "2016" @default.
- W2480851940 type Work @default.
- W2480851940 sameAs 2480851940 @default.
- W2480851940 citedByCount "49" @default.
- W2480851940 countsByYear W24808519402016 @default.
- W2480851940 countsByYear W24808519402017 @default.
- W2480851940 countsByYear W24808519402018 @default.
- W2480851940 countsByYear W24808519402019 @default.
- W2480851940 countsByYear W24808519402020 @default.
- W2480851940 countsByYear W24808519402021 @default.
- W2480851940 countsByYear W24808519402022 @default.
- W2480851940 countsByYear W24808519402023 @default.
- W2480851940 crossrefType "journal-article" @default.
- W2480851940 hasAuthorship W2480851940A5005567441 @default.
- W2480851940 hasAuthorship W2480851940A5008078906 @default.
- W2480851940 hasAuthorship W2480851940A5010621055 @default.
- W2480851940 hasAuthorship W2480851940A5071878173 @default.
- W2480851940 hasConcept C112705442 @default.
- W2480851940 hasConcept C126322002 @default.
- W2480851940 hasConcept C168563851 @default.
- W2480851940 hasConcept C197934379 @default.
- W2480851940 hasConcept C23131810 @default.
- W2480851940 hasConcept C2777575956 @default.
- W2480851940 hasConcept C42404028 @default.
- W2480851940 hasConcept C535046627 @default.
- W2480851940 hasConcept C59491497 @default.
- W2480851940 hasConcept C71924100 @default.
- W2480851940 hasConceptScore W2480851940C112705442 @default.
- W2480851940 hasConceptScore W2480851940C126322002 @default.
- W2480851940 hasConceptScore W2480851940C168563851 @default.
- W2480851940 hasConceptScore W2480851940C197934379 @default.
- W2480851940 hasConceptScore W2480851940C23131810 @default.
- W2480851940 hasConceptScore W2480851940C2777575956 @default.
- W2480851940 hasConceptScore W2480851940C42404028 @default.
- W2480851940 hasConceptScore W2480851940C535046627 @default.
- W2480851940 hasConceptScore W2480851940C59491497 @default.
- W2480851940 hasConceptScore W2480851940C71924100 @default.
- W2480851940 hasIssue "8" @default.
- W2480851940 hasLocation W24808519401 @default.
- W2480851940 hasLocation W24808519402 @default.
- W2480851940 hasOpenAccess W2480851940 @default.
- W2480851940 hasPrimaryLocation W24808519401 @default.
- W2480851940 hasRelatedWork W2075693904 @default.
- W2480851940 hasRelatedWork W2156283049 @default.
- W2480851940 hasRelatedWork W2316954211 @default.
- W2480851940 hasRelatedWork W2427075784 @default.
- W2480851940 hasRelatedWork W2503283136 @default.
- W2480851940 hasRelatedWork W2761967325 @default.
- W2480851940 hasRelatedWork W4205398759 @default.
- W2480851940 hasRelatedWork W4233707738 @default.
- W2480851940 hasRelatedWork W4380149859 @default.
- W2480851940 hasRelatedWork W4380149993 @default.
- W2480851940 hasVolume "165" @default.