{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T11:08:46Z","timestamp":1778843326470,"version":"3.51.4"},"reference-count":23,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2025,11,14]],"date-time":"2025-11-14T00:00:00Z","timestamp":1763078400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>The objective of the study is to analyze the pharmacology, efficacy, and safety of ustekinumab-ttwe in the treatment of moderate-to-severe plaque psoriasis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources:<\/jats:title>\n                    <jats:p>PubMed, Embase, and ClinicalTrials.gov were searched using the following search terms: ustekinumab, biosimilar, ustekinumab-ttwe, Pyzchiva, SB17, and psoriasis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Selection and Data Extraction:<\/jats:title>\n                    <jats:p>Articles published in English between January 9, 2015, and June 21, 2025, related to the pharmacology, pharmacokinetics, efficacy, safety, immunogenicity, and clinical trials were reviewed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis:<\/jats:title>\n                    <jats:p>Search results from PubMed and EMBASE yielded 259 articles, and 12 studies from Clinicaltrials.gov. Only 2 clinical trials of ustekinumb-ttwe\u2019s use in psoriasis were identified and were included in analysis. The pharmacokinetic parameters of ustekinumab-ttwe (SB17), European Union-sourced ustekinumab (EU-UST) and United States-sourced ustekinumab (US-UST) were similar in its phase I trial. In addition, a phase III trial comparing the efficacy of ustekinumab-ttwe to ustekinumab showed that the difference of percent change from baseline of the Psoriasis Area and Severity Index (PASI) score between the 2 groups was comparable with a change of 85.7% for ustekinumab-ttwe (95% confidence interval [CI] = [\u20133.78, 2,58]) and 86.4% for ustekinumab (90% CI = [\u20133.34, 1.93]).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:<\/jats:title>\n                    <jats:p>The pharmacology, pharmacokinetics, efficacy, safety, and immunogenicity of ustekinumab-ttwe and reference ustekinumab were equivalent, demonstrating its role as a biosimilar. There are no current clinical trials directly comparing ustekinumab-ttwe with ustekinumab\u2019s other biosimilars.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Ustekinumab-ttwe\u2019s equivalence to its reference biologic ustekinumab creates another treatment option for patients with moderate- to- severe plaque psoriasis.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280251375990","type":"journal-article","created":{"date-parts":[[2025,11,14]],"date-time":"2025-11-14T11:11:01Z","timestamp":1763118661000},"page":"608-615","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Pyzchiva (ustekinumab-ttwe): A New Biosimilar for Psoriasis"],"prefix":"10.1177","volume":"60","author":[{"given":"Bianca","family":"Lindecker","sequence":"first","affiliation":[{"name":"Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Science, Wayne State University, Detroit, MI, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0540-785X","authenticated-orcid":false,"given":"Christopher","family":"Giuliano","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Science, Wayne State University, Detroit, MI, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8729-7710","authenticated-orcid":false,"given":"Pramodini B.","family":"Kale-Pradhan","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Science, Wayne State University, Detroit, MI, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,11,14]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.4006"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2021.2007"},{"key":"e_1_3_2_4_2","unstructured":"Merative Micromedex. RED BOOK\u2014Stelara. Accessed June 19 2025. https:\/\/www.micromedexsolutions.com\/micromedex2\/librarian\/CS\/A4236E\/ND_PR\/evidencexpert\/ND_P\/evidencexpert\/DUPLICATIONSHIELDSYNC\/95F4DF\/ND_PG\/evidencexpert\/ND_B\/evidencexpert\/ND_AppProduct\/evidencexpert\/ND_T\/evidencexpert\/PFActionId\/redbook.FindRedBook?navitem=topRedBook&isToolPage=true."},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2023.5429"},{"key":"e_1_3_2_6_2","unstructured":"Research C for DE and. Biosimilars Basics for Patients. Published online August 9 2024. Accessed June 19 2025. https:\/\/www.fda.gov\/drugs\/biosimilars\/biosimilars-basics-patients"},{"key":"e_1_3_2_7_2","unstructured":"Merative Micromedex. REDBOOK\u2014Pyzchiva. Accessed June 19 2025. https:\/\/www.micromedexsolutions.com\/micromedex2\/librarian\/CS\/B8A853\/ND_PR\/evidencexpert\/ND_P\/evidencexpert\/DUPLICATIONSHIELDSYNC\/8DC99C\/ND_PG\/evidencexpert\/ND_B\/evidencexpert\/ND_AppProduct\/evidencexpert\/ND_T\/evidencexpert\/PFActionId\/redbook.FindRedBook?navitem=topRedBook&isToolPage=true"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2024.10.299"},{"key":"e_1_3_2_9_2","unstructured":"Sandoz Inc. Pyzchiva (ustekinumab-ttwe) [package insert]. Accessed June 19 2025. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2024\/761373s002 761425s002lbl.pdf."},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.5414\/CP204492"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2024.1401178"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2024.04.045"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2023.07.027"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2024.02.025"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-4642(23)00136-0"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.2147\/PHMT.S75836"},{"key":"e_1_3_2_17_2","unstructured":"Biocon Biologics UK Ltd. A randomized double-blind parallel group multicenter phase 3 study to compare the efficacy and safety of Bmab 1200 and stelara in patients with moderate to severe chronic plaque psoriasis. clinicaltrials.gov; 2024. Accessed June 19 2025. https:\/\/clinicaltrials.gov\/study\/NCT05335356"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1080\/13543784.2025.2500334"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1093\/bjd\/ljae402"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1080\/14712598.2023.2235263"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-025-03138-2"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-023-00630-5"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2024.10.104"},{"key":"e_1_3_2_24_2","unstructured":"Dong-A ST Co. Ltd. A randomized double-blind multicentric parallel group therapeutic equivalence study comparing efficacy safety and immunogenicity of subcutaneous DMB-3115 and Stelara\u00ae in patients with moderate to severe chronic plaque psoriasis. clinicaltrials.gov; 2024. 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