{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,4]],"date-time":"2023-10-04T07:47:58Z","timestamp":1696405678765},"reference-count":21,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,3,25]],"date-time":"2015-03-25T00:00:00Z","timestamp":1427241600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Deutsche Derma Gesell"],"published-print":{"date-parts":[[2015,4]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Biosimilars for psoriasis treatment are currently being developed. Comparison of their efficacy and safety is a challenge. For approval, the European Medicines Agency (EMA) considers indirect evidence from other indications (for example, rheumatoid arthritis) as sufficient.<\/jats:p><jats:p>Systematic review of biosimilars for psoriasis and other indications, review of ongoing trials in trial registers.<\/jats:p><jats:p>Systematic search for randomized controlled trials (RCT) on biosimilars to adalimumab, etanercept, infliximab, and ustekinumab compared to their reference medication: (1) Publications in Medline, Medline In\u2010Process, Embase, Cochrane Library (efficacy, safety, immunogenicity) and (2) ongoing studies in clinical trial registers.<\/jats:p><jats:p>No trials on biosimilars in psoriasis patients were identified. As to the infliximab biosimilar, there is data on patients with ankylosing spondylitis and rheumatoid arthritis, indicating no clinically relevant differences regarding efficacy and safety. Currently, there are two registered studies of an adalimumab biosimilar and one study of an etanercept biosimilar in psoriasis patients. Further ongoing studies on biosimilars to adalimumab, etanercept, and infliximab \u2013 all in rheumatoid arthritis patients \u2013 were identified.<\/jats:p><jats:p>There is currently only limited data regarding RCTs with biosimilars. Provision of further clinical data and inclusion of patients in patient registers will be crucial.<\/jats:p>","DOI":"10.1111\/ddg.12621","type":"journal-article","created":{"date-parts":[[2015,3,25]],"date-time":"2015-03-25T15:37:46Z","timestamp":1427297866000},"page":"294-300","source":"Crossref","is-referenced-by-count":12,"title":["Biosimilars: a systematic review of published and ongoing clinical trials of antipsoriatics in chronic inflammatory diseases"],"prefix":"10.1111","volume":"13","author":[{"given":"Alexander","family":"Nast","sequence":"first","affiliation":[{"name":"Division of Evidence Based Medicine (dEBM) Department of Dermatology, Charit\u00e8 \u2013 Universit\u00e4tsmedizin Berlin  Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefanie","family":"Rosumeck","sequence":"additional","affiliation":[{"name":"Division of Evidence Based Medicine (dEBM) Department of Dermatology, Charit\u00e8 \u2013 Universit\u00e4tsmedizin Berlin  Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karin","family":"Seidenschnur","sequence":"additional","affiliation":[{"name":"Division of Evidence Based Medicine (dEBM) Department of Dermatology, Charit\u00e8 \u2013 Universit\u00e4tsmedizin Berlin  Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,3,25]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"European Medicines Agency.European Medicines Agency \u2013 Q&A: Similar biological products \u2013 Biosimilar medicines.2014.http:\/\/www.ema.europa.eu:80\/ema\/index.jsp?curl=pages\/special_topics\/document_listing\/document_listing_000318.jsp. Accessed: 2014 Jun 02."},{"key":"e_1_2_7_3_1","unstructured":"European Medicines Agency.Questions and answers on biosimilar medicines (similar biological medicinal products).2012.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Medicine_QA\/2009\/12\/WC500020062.pdf. Accessed: 2014 Jun 02."},{"key":"e_1_2_7_4_1","unstructured":"European Medicines Agency.Guideline on similar biological medicinal products containing monoclonal antibodies \u2013 non\u2010clinical and clinical issues.2012.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2012\/06\/WC500128686.pdf. Accessed: 2014 Jun 02."},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d5928"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-203090"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-203090"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-203091"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-eular.1850"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2012-203091"},{"key":"e_1_2_7_11_1","unstructured":"Amgen.Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (Humira\u00c6) in Adults With Moderate to Severe Plaque Psoriasis. In:ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000\u2010 [cited 2014 May 26]. Available fromhttp:\/\/ClinicalTrials.gov\/show\/NCT01970488. NLM Identifier: NCT01970488."},{"key":"e_1_2_7_12_1","unstructured":"Sandoz.Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira (ADACCESS). In:ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000\u2010 [cited 2014 May 26]. Available fromhttp:\/\/ClinicalTrials.gov\/show\/NCT02016105. NLM Identifier: NCT02016105."},{"key":"e_1_2_7_13_1","unstructured":"Amgen.Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis (RA). In:ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000\u2010 [cited 2014 May 26]. Available fromhttp:\/\/ClinicalTrials.gov\/show\/NCT01970475. NLM Identifier: NCT01970475."},{"key":"e_1_2_7_14_1","unstructured":"Sandoz.Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel (EGALITY). In:ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000\u2010 [cited 2014 May 26]. Available fromhttp:\/\/ClinicalTrials.gov\/show\/NCT01891864. NLM Identifier: NCT01891864."},{"key":"e_1_2_7_15_1","unstructured":"Samsung Bioepis Co. Ltd.A Study Comparing SB4 to Enbrel\u00c6 in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy. In:ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000\u2010 [cited 2014 May 26]. Available fromhttp:\/\/ClinicalTrials.gov\/show\/NCT01895309. NLM Identifier: NCT01895309."},{"key":"e_1_2_7_16_1","unstructured":"Hanwha Chemical.Randomized Double\u2010blind Parallel Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA Patients. In:ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000\u2010 [cited 2014 May 26]. Available fromhttp:\/\/ClinicalTrials.gov\/show\/NCT01270997. NLM Identifier: NCT01270997."},{"key":"e_1_2_7_17_1","unstructured":"Coherus Biosciences Inc.Comparison of CHS\u20100214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA) (CHS\u20100214\u201302). In:ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000\u2010 [cited 2014 May 26]. Available fromhttp:\/\/ClinicalTrials.gov\/show\/NCT02115750. NLM Identifier: NCT02115750."},{"key":"e_1_2_7_18_1","unstructured":"Samsung Bioepis Co. Ltd.A Study Comparing SB2 to Remicade\u00c6 in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy. In:ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000\u2010 [cited 2014 May 26]. Available fromhttp:\/\/ClinicalTrials.gov\/show\/NCT01936181. NLM Identifier: NCT01936181."},{"key":"e_1_2_7_19_1","unstructured":"Nichi\u2010Iko Pharmaceutical Co. Ltd.A Phase 3 Study of NI\u2010071 in Patients With Rheumatoid Arthritis. In:ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000\u2010 [cited 2014 May 26]. Available fromhttp:\/\/ClinicalTrials.gov\/show\/NCT01927263. NLM Identifier: NCT01927263."},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1038\/nbt.1839"},{"key":"e_1_2_7_21_1","first-page":"452","article-title":"Biosimilars: Das Wettrennen ist in vollem Gange","volume":"111","author":"Zylka\u2010Menhorn V","year":"2014","journal-title":"Dtsch Arztebl International"},{"key":"e_1_2_7_22_1","doi-asserted-by":"crossref","first-page":"306","DOI":"10.1111\/ddg.12294","article-title":"Biosimilars in psoriasis: what can we expect","volume":"12","author":"Radtke MA","year":"2014","journal-title":"J Dtsch Dermatol Ges"}],"container-title":["JDDG: Journal der Deutschen Dermatologischen Gesellschaft"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fddg.12621","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fddg.12621","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ddg.12621","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,3]],"date-time":"2023-10-03T03:35:27Z","timestamp":1696304127000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ddg.12621"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,3,25]]},"references-count":21,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2015,4]]}},"alternative-id":["10.1111\/ddg.12621"],"URL":"https:\/\/doi.org\/10.1111\/ddg.12621","archive":["Portico"],"relation":{},"ISSN":["1610-0379","1610-0387"],"issn-type":[{"value":"1610-0379","type":"print"},{"value":"1610-0387","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,3,25]]}}}