{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T07:59:07Z","timestamp":1792051147530,"version":"4.4.0"},"reference-count":35,"publisher":"American Medical Association (AMA)","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Dermatol"],"published-print":{"date-parts":[[2023,7,1]]},"abstract":"Importance<\/jats:title>Biosimilars have the potential to reduce costs for the management of moderate-to-severe psoriasis compared with originators. However, the extrapolation of evidence enables the approval of a biosimilar for use in indications held by the originator without directly being studied in clinical trials. Thus, biosimilars can be approved for psoriasis based on extrapolated evidence from other diseases. The availability of evidence for the effectiveness and safety of biosimilars for the treatment of psoriasis is therefore unclear.<\/jats:p><\/jats:sec>Objective<\/jats:title>To compare the efficacy\/effectiveness and safety of biosimilars with originator biologics for the treatment of patients with psoriasis.<\/jats:p><\/jats:sec>Evidence Review<\/jats:title>MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov, and The European Union Clinical Trials Register were searched in August 2022. Eligible studies were appraised using the Cochrane Risk of Bias 2 and ROBINS-I tools. All analyses were conducted from September 2022 to November 2022.<\/jats:p><\/jats:sec>Findings<\/jats:title>Fourteen trials (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) were included. Twelve trials compared biosimilars with originators in originator-naive patients (starters), and 11 trials compared switching from originator to biosimilar (switchers) with continuous originator treatments. There was no clinically or statistically significant difference in rates of achieving 75% improvement in Psoriasis Area and Severity Index scores and risks of adverse events (AEs) at week 16 and week 52 between the comparators. Two cohort studies showed no difference in effectiveness and safety outcomes between originators and biosimilars, whereas 1 study reported more AEs in patients who switched to biosimilars of adalimumab at 12 months. Three trials showed low risk of bias, whereas 11 trials had moderate risk of bias. All cohort studies had moderate to high risk of bias.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>In this systematic review, there was no clinically or statistically significant difference in the efficacy and safety between biosimilars and originators for the treatment of patients with psoriasis. Most of the available evidence was based on randomized clinical trials, although high-quality real-world evidence was lacking. Future studies are needed to examine the long-term effectiveness and safety of biosimilars for the treatment of patients with psoriasis.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamadermatol.2023.1338","type":"journal-article","created":{"date-parts":[[2023,5,31]],"date-time":"2023-05-31T15:33:07Z","timestamp":1685547187000},"page":"763","source":"Crossref","is-referenced-by-count":26,"title":["Biosimilars for the Treatment of Psoriasis"],"prefix":"10.1001","volume":"159","author":[{"given":"Duc Binh","family":"Phan","sequence":"first","affiliation":[{"name":"Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Elyoussfi","sequence":"additional","affiliation":[{"name":"Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Stevenson","sequence":"additional","affiliation":[{"name":"The University of Manchester Library, The University of Manchester, Manchester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Lunt","sequence":"additional","affiliation":[{"name":"Versus Arthritis Epidemiology Unit, The University of Manchester, Manchester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard B.","family":"Warren","sequence":"additional","affiliation":[{"name":"Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zenas Z. N.","family":"Yiu","sequence":"additional","affiliation":[{"name":"Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, NIHR Manchester Biomedical Research Centre, Manchester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"4","key":"drv230002r1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD011535.pub4","article-title":"Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.","volume":"4","author":"Sbidian","year":"2021","journal-title":"Cochrane Database Syst Rev"},{"issue":"1","key":"drv230002r2","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1007\/s40744-016-0029-z","article-title":"Psoriatic arthritis and burden of disease: patient perspectives from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey.","volume":"3","author":"Kavanaugh","year":"2016","journal-title":"Rheumatol Ther"},{"issue":"1","key":"drv230002r3","doi-asserted-by":"publisher","first-page":"87","DOI":"10.1007\/s40257-015-0169-x","article-title":"US perspectives in the management of psoriasis and psoriatic arthritis: patient and physician results from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey.","volume":"17","author":"Lebwohl","year":"2016","journal-title":"Am J Clin Dermatol"},{"issue":"14","key":"drv230002r5","doi-asserted-by":"publisher","first-page":"1403","DOI":"10.1056\/NEJMoa040528","article-title":"Pure red-cell aplasia and epoetin therapy.","volume":"351","author":"Bennett","year":"2004","journal-title":"N Engl J Med"},{"issue":"4","key":"drv230002r6","doi-asserted-by":"publisher","first-page":"599","DOI":"10.1093\/ckj\/sfw030","article-title":"Pure red cell aplasia induced by epoetin zeta.","volume":"9","author":"Panichi","year":"2016","journal-title":"Clin Kidney J"},{"issue":"4","key":"drv230002r7","doi-asserted-by":"publisher","first-page":"483","DOI":"10.1007\/s40257-020-00507-1","article-title":"Safety and effectiveness of anti-tumor necrosis factor-alpha biosimilar agents in the treatment of psoriasis.","volume":"21","author":"Reynolds","year":"2020","journal-title":"Am J Clin Dermatol"},{"issue":"6","key":"drv230002r8","doi-asserted-by":"publisher","first-page":"1636","DOI":"10.1016\/j.jaad.2021.02.019","article-title":"Risk of liver disease in patients with psoriasis, psoriatic arthritis, and rheumatoid arthritis receiving methotrexate: a population-based study.","volume":"84","author":"Gelfand","year":"2021","journal-title":"J Am Acad Dermatol"},{"issue":"12","key":"drv230002r11","doi-asserted-by":"publisher","first-page":"1283","DOI":"10.1016\/j.jclinepi.2011.01.012","article-title":"GRADE guidelines 6. rating the quality of evidence\u2013imprecision.","volume":"64","author":"Guyatt","year":"2011","journal-title":"J Clin Epidemiol"},{"issue":"1","key":"drv230002r12","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1159\/000365390","article-title":"Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data.","volume":"230","author":"Basra","year":"2015","journal-title":"Dermatology"},{"issue":"2","key":"drv230002r22","doi-asserted-by":"publisher","first-page":"509","DOI":"10.1111\/bjd.16102","article-title":"Safety, efficacy and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis.","volume":"178","author":"Egeberg","year":"2018","journal-title":"Br J Dermatol"},{"issue":"4","key":"drv230002r24","doi-asserted-by":"publisher","first-page":"318","DOI":"10.23736\/S2784-8671.22.07224-3","article-title":"Biosimilar versus originator etanercept: a real-life clinical study.","volume":"157","author":"Giordano","year":"2022","journal-title":"Ital J Dermatol Venerol"},{"issue":"6","key":"drv230002r25","doi-asserted-by":"publisher","first-page":"676","DOI":"10.1001\/jamadermatol.2021.0221","article-title":"Outcomes following a mandatory nonmedical switch from adalimumab originator to adalimumab biosimilars in patients with psoriasis.","volume":"157","author":"Loft","year":"2021","journal-title":"JAMA Dermatol"},{"issue":"4","key":"drv230002r30","doi-asserted-by":"publisher","first-page":"463","DOI":"10.1007\/s40265-018-0881-y","article-title":"Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes.","volume":"78","author":"Cohen","year":"2018","journal-title":"Drugs"},{"issue":"4","key":"drv230002r31","doi-asserted-by":"publisher","first-page":"1529","DOI":"10.1111\/bcp.v88.4","article-title":"Switching between reference adalimumab and biosimilars in chronic immune-mediated inflammatory diseases: a systematic literature review.","volume":"88","author":"Garc\u00eda-Beloso","year":"2022","journal-title":"Br J Clin Pharmacol"},{"issue":"1","key":"drv230002r32","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1111\/apt.14997","article-title":"Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.","volume":"49","author":"Feagan","year":"2019","journal-title":"Aliment Pharmacol Ther"},{"issue":"4","key":"drv230002r33","doi-asserted-by":"publisher","first-page":"383","DOI":"10.1016\/j.jclinepi.2010.04.026","article-title":"GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables.","volume":"64","author":"Guyatt","year":"2011","journal-title":"J Clin Epidemiol"},{"issue":"5","key":"drv230002r34","doi-asserted-by":"publisher","first-page":"581","DOI":"10.1001\/jamadermatol.2018.0183","article-title":"Comparison of drug discontinuation, effectiveness, and safety between clinical trial eligible and ineligible patients in BADBIR.","volume":"154","author":"Mason","year":"2018","journal-title":"JAMA Dermatol"},{"issue":"6","key":"drv230002r35","doi-asserted-by":"publisher","first-page":"1265","DOI":"10.1111\/bjd.v181.6","article-title":"A standardization approach to compare treatment safety and effectiveness outcomes between clinical trials and real-world populations in psoriasis.","volume":"181","author":"Yiu","year":"2019","journal-title":"Br J Dermatol"},{"key":"drv230002r4","unstructured":"European Medicines Agency. Biosimilar medicines: marketing authorisation. 2022. Accessed August 10, 2022. https:\/\/www.ema.europa.eu\/en\/human-regulatory\/marketing-authorisation\/biosimilar-medicines-marketing-authorisation"},{"key":"drv230002r9","unstructured":"Higgins? JPT, Thomas? J, Chandler? J, Cumpston? M, Li? T. MJ P. VA W, ed. Cochrane Handbook for Systematic Reviews of Interventions. 2011. Accessed August 10, 2022. http:\/\/www.training.cochrane.org\/handbook"},{"key":"drv230002r10","unstructured":"Sch\u00fcnemann? H, Brozek? J. G G. A O, ed. GRADE handbook for grading quality of evidence and strength of recommendations. The GRADE Working Group; 2013. Accessed August 10, 2022. https:\/\/gradepro.org\/guidelinedevelopment.org\/handbook"},{"key":"drv230002r13","unstructured":"NCT03849404. Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis. 2019. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03849404"},{"key":"drv230002r14","unstructured":"NCT01970488. Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA) in Adults With Moderate to Severe Plaque Psoriasis. 2014. Accessed August 10, 2022. https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01970488"},{"key":"drv230002r15","unstructured":"NCT02762955. Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira in Patients With Moderate to Severe Plaque Psoriasis. 2017. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02762955"},{"key":"drv230002r16","unstructured":"NCT02850965. Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis. 2018. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02850965"},{"key":"drv230002r17","unstructured":"NCT03210259. The VOLTAIRE-X Trial Looks at the Effect of Switching Between Humira and BI 695501 in Patients With Plaque Psoriasis. 2019. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03210259"},{"key":"drv230002r18","unstructured":"NCT04673786. A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis. 2021. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04673786"},{"key":"drv230002r19","unstructured":"NCT02489227. Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis. 2016. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02489227"},{"key":"drv230002r20","unstructured":"NCT02134210. Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO). 2015. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02134210"},{"key":"drv230002r21","unstructured":"NCT02148640. The NOR-SWITCH Study. 2016. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02148640"},{"key":"drv230002r23","unstructured":"NCT02660580. MSB11022 in Moderate to Severe Chronic Plaque Psoriasis. 2016. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02660580"},{"key":"drv230002r26","unstructured":"NCT02581345. Phase 3 Study of M923 and Humira in Subjects With Chronic Plaque-type Psoriasis. 2017. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02581345"},{"key":"drv230002r27","unstructured":"NCT01891864. Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel. 2014. Accessed August 10, 2022. https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01891864"},{"key":"drv230002r28","unstructured":"NCT02016105. Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira. 2015. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02016105"},{"key":"drv230002r29","unstructured":"NCT03316781. Study of Efficacy and Safety of HLX03 in Subjects With Moderate to Severe Plaque Psoriasis. 2018. Accessed August 10, 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/results\/NCT03316781"}],"container-title":["JAMA Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamadermatology\/articlepdf\/2805555\/jamadermatology_phan_2023_rv_230002_1689096769.65522.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,7,19]],"date-time":"2023-07-19T15:19:24Z","timestamp":1689779964000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamadermatology\/fullarticle\/2805555"}},"subtitle":["A Systematic Review of Clinical Trials and Observational Studies"],"short-title":[],"issued":{"date-parts":[[2023,7,1]]},"references-count":35,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2023,7,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamadermatol.2023.1338","relation":{},"ISSN":["2168-6068"],"issn-type":[{"value":"2168-6068","type":"print"}],"subject":[],"published":{"date-parts":[[2023,7,1]]}}}