{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:16:16Z","timestamp":1789690576722,"version":"4.0.1"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T00:00:00Z","timestamp":1780012800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,18]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>ABP 654 is a biosimilar to ustekinumab reference product (RP). It is approved for the treatment of patients with moderate-to-severe plaque psoriasis and other autoimmune disorders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To demonstrate the interchangeability of ABP 654 and ustekinumab RP following multiple switches.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this randomized, double-blinded study that evaluated pharmacokinetics (PK), efficacy, immunogenicity and safety, patients with moderate-to-severe plaque psoriasis received a subcutaneous injection of ustekinumab RP 45\u2005mg or 90\u2005mg (baseline bodyweight \u2264 100\u2005kg or &amp;gt; 100\u2005kg, respectively) on day 1 (week 0), week 4 and week 16 (run-in period). At week 28, patients with a 50% improvement in the Psoriasis Area and Severity Index (PASI) or better response were randomized in a 1 : 1 ratio to the \u2018continued-use\u2019 group or \u2018switching\u2019 group. Those in the continued-use group received ustekinumab RP at the same dose as in the run-in period at weeks 28, 40 and 52, while the switching group received ABP 654 at week 28, ustekinumab RP at week 40 and ABP 654 at week 52. The primary endpoints were area under the curve over the dosing interval (AUCtau) and maximum concentration (Cmax) between weeks 52 and 64. Secondary endpoints included time to maximum concentration between weeks 52 and 64, trough concentration at steady state between weeks 28 and 52, percentage improvement in PASI from baseline at week 64, \u2265 75% improvement in (PASI 75) and 100% improvement in PASI (PASI 100) responses at week 64, the incidence of antidrug antibodies (ADAs) and the incidence and severity of adverse events (AEs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of the 494 enrolled patients, 453 successfully completed the run-in period and were randomized to the continued-use (n = 225) or switching (n = 228) groups. The point estimates and 90% confidence intervals (CIs) of the geometric mean ratios for AUCtau and Cmax between weeks 52 and 64 were 0.93 (90% CI 0.89\u20130.98) and 0.95 (90% CI 0.90\u20131.00), respectively. As both 90% CIs fell within the prespecified similarity margin of 0.8\u20131.25, PK similarity was demonstrated between the switching and continued-use groups. In addition, efficacy, and the incidence of ADAs and AEs were also similar between the groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These results support the interchangeability of ABP 654 and ustekinumab RP.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/bjd\/ljag218","type":"journal-article","created":{"date-parts":[[2026,5,28]],"date-time":"2026-05-28T11:43:54Z","timestamp":1779968634000},"page":"583-591","source":"Crossref","is-referenced-by-count":0,"title":["Repeated switching between biosimilar ABP 654 and reference ustekinumab in patients with\u00a0moderate-to-severe plaque psoriasis: a\u00a0randomized\u00a0double-blinded clinical trial to support\u00a0interchangeability"],"prefix":"10.1093","volume":"195","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2633-985X","authenticated-orcid":false,"given":"Andrew","family":"Blauvelt","sequence":"first","affiliation":[{"name":"Blauvelt Consulting LLC , Annapolis, MD ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerry","family":"Bagel","sequence":"additional","affiliation":[{"name":"Psoriasis Treatment Center of Central New Jersey , East Windsor, NJ ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1330-1502","authenticated-orcid":false,"given":"Andreas","family":"Pinter","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Venereology and Allergology, University Hospital Frankfurt am Main , Frankfurt am Main ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8513-550X","authenticated-orcid":false,"given":"Diamant","family":"Tha\u00e7i","sequence":"additional","affiliation":[{"name":"Institute and Comprehensive Center for Inflammation Medicine, University of L\u00fcbeck , L\u00fcbeck ,","place":["Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-1250-3197","authenticated-orcid":false,"given":"Muhan","family":"Zhou","sequence":"additional","affiliation":[{"name":"Amgen Inc. , Thousand Oaks, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia","family":"Cao","sequence":"additional","affiliation":[{"name":"Amgen Inc. , Thousand Oaks, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel\u00a0T","family":"Mytych","sequence":"additional","affiliation":[{"name":"Amgen Inc. , Thousand Oaks, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-5909-5002","authenticated-orcid":false,"given":"Vincent","family":"Chow","sequence":"additional","affiliation":[{"name":"Amgen Inc. , Thousand Oaks, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7680-9007","authenticated-orcid":false,"given":"Janet","family":"Franklin","sequence":"additional","affiliation":[{"name":"Amgen Inc. , Thousand Oaks, CA ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,5,29]]},"reference":[{"key":"2026091719524241800_ljag218-B1","author":"WEZLANA\u00ae (ustekinumab-auub)"},{"key":"2026091719524241800_ljag218-B2","author":"European Medicines Agency."},{"key":"2026091719524241800_ljag218-B3","doi-asserted-by":"crossref","first-page":"282","DOI":"10.1111\/bjd.14267","article-title":"Biosimilars for psoriasis: preclinical analytical assessment to determine similarity","volume":"174","author":"Blauvelt","year":"2016","journal-title":"Br J Dermatol"},{"key":"2026091719524241800_ljag218-B4","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1111\/bjd.15067","article-title":"Biosimilars for psoriasis: clinical studies to determine similarity","volume":"177","author":"Blauvelt","year":"2017","journal-title":"Br J Dermatol"},{"key":"2026091719524241800_ljag218-B5","doi-asserted-by":"crossref","first-page":"421","DOI":"10.1007\/s40268-023-00441-7","article-title":"Analytical and functional similarity of the biosimilar candidate ABP 654 to ustekinumab reference product","volume":"23","author":"Cantin","year":"2023","journal-title":"Drugs R D"},{"key":"2026091719524241800_ljag218-B6","doi-asserted-by":"crossref","first-page":"826","DOI":"10.1093\/bjd\/ljae402","article-title":"Efficacy and safety of the ustekinumab biosimilar abp 654 in patients with moderate-to-severe plaque psoriasis: a randomized, double-blinded, active-controlled, comparative clinical study over 52 weeks","volume":"195","author":"Blauvelt","year":"2025","journal-title":"Br J Dermatol"},{"key":"2026091719524241800_ljag218-B7","doi-asserted-by":"crossref","first-page":"863","DOI":"10.1002\/cpdd.1301","article-title":"Pharmacokinetic similarity of ABP 654, an ustekinumab biosimilar candidate: results from a randomized, double-blind study in healthy subjects","volume":"12","author":"Chow","year":"2023","journal-title":"Clin Pharmacol Drug Dev"},{"key":"2026091719524241800_ljag218-B8","doi-asserted-by":"crossref","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"},{"key":"2026091719524241800_ljag218-B9","first-page":"30","volume-title":"Generic-substitution laws","author":"Vivian","year":"2008"},{"key":"2026091719524241800_ljag218-B10","author":"US Food and Drug Administration"},{"key":"2026091719524241800_ljag218-B11","author":"STELARA\u00ae (ustekinumab)"},{"key":"2026091719524241800_ljag218-B12","author":"U.S. Department of Health and Human Services"},{"key":"2026091719524241800_ljag218-B13","doi-asserted-by":"crossref","first-page":"e0292231","DOI":"10.1371\/journal.pone.0292231","article-title":"Safety outcomes when switching between biosimilars and reference biologics: a systematic review and meta-analysis","volume":"18","author":"Herndon","year":"2023","journal-title":"PLOS ONE"},{"key":"2026091719524241800_ljag218-B14","doi-asserted-by":"crossref","first-page":"1881","DOI":"10.1007\/s40265-021-01601-2","article-title":"Safety, immunogenicity and interchangeability of biosimilar monoclonal antibodies and fusion proteins: a regulatory perspective","volume":"81","author":"Kurki","year":"2021","journal-title":"Drugs"},{"key":"2026091719524241800_ljag218-B15","doi-asserted-by":"crossref","DOI":"10.1080\/09546634.2022.2140569","article-title":"Real-world outcomes following switching from anti-tnf reference products to biosimilars for the treatment of psoriasis","volume":"34","author":"Ruda","year":"2023","journal-title":"J Dermatolog Treat"},{"key":"2026091719524241800_ljag218-B16","author":"US Food and Drug Administration"}],"container-title":["British Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/bjd\/advance-article-pdf\/doi\/10.1093\/bjd\/ljag218\/68429708\/ljag218.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/bjd\/article-pdf\/195\/4\/583\/68429708\/ljag218.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/bjd\/article-pdf\/195\/4\/583\/68429708\/ljag218.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T23:52:56Z","timestamp":1789689176000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/bjd\/article\/195\/4\/583\/8697829"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,29]]},"references-count":16,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2026,5,29]]},"published-print":{"date-parts":[[2026,9,18]]}},"URL":"https:\/\/doi.org\/10.1093\/bjd\/ljag218","relation":{},"ISSN":["0007-0963","1365-2133"],"issn-type":[{"value":"0007-0963","type":"print"},{"value":"1365-2133","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,10]]},"published":{"date-parts":[[2026,5,29]]}}}