{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T03:59:48Z","timestamp":1780891188250,"version":"3.54.1"},"reference-count":9,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T00:00:00Z","timestamp":1773878400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T00:00:00Z","timestamp":1773878400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacology Res &amp; Perspec"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    ABP 501, a monoclonal anti\u2010tumor necrosis factor antibody, was the first adalimumab biosimilar approved in the US and EU as a 50\u2009mg\/mL formulation. An ABP 501 100\u2009mg\/mL high\u2010concentration formulation is also now approved. This study compares pharmacokinetics (PK), safety, and immunogenicity of the low\u2010 (ABP 501\u2010LCF) and high\u2010concentration (ABP 501\u2010HCF) formulations in healthy adults. This was a randomized, single\u2010blind, single\u2010dose, parallel\u2010group study in healthy adults. Participants were randomized to receive 40\u2009mg of ABP 501 as HCF or LCF. Primary PK endpoints were area under the concentration\u2010time curve from time 0 extrapolated to infinity (AUC\n                    <jats:sub>inf<\/jats:sub>\n                    ) and maximum observed concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ) with a 90% confidence interval (CI) for the ratio of least square (LS) geometric means (GM) with a similarity margin of 0.80\u20131.25. Secondary endpoints included other PK parameters, safety, and immunogenicity. Baseline demographic and other characteristics were comparable between groups. Following study injection, ratios of LS GM (90% CIs) for AUC\n                    <jats:sub>inf<\/jats:sub>\n                    and C\n                    <jats:sub>max<\/jats:sub>\n                    between ABP 501\u2010HCF and ABP 501\u2010LCF were 1.04 (0.9634, 1.1297) and 1.06 (0.9960, 1.138), falling within the similarity margin. Both formulations were well tolerated with comparable adverse events. The occurrence of anti\u2010drug antibodies and neutralizing antibodies was comparable between groups. This study demonstrates PK similarity between ABP 501\u2010HCF and ABP 501\u2010LCF following a single subcutaneous injection in healthy adults. Immunogenicity and safety profiles were also similar. Given the totality of evidence of similarity of ABP 501 with adalimumab reference product (RP), it is anticipated that ABP 501\u2010HCF will perform similarly to the RP.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration:<\/jats:bold>\n                    NCT04270747.\n                  <\/jats:p>","DOI":"10.1002\/prp2.70236","type":"journal-article","created":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T04:16:28Z","timestamp":1773980188000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic, Safety, and Immunogenicity Similarity of High\u2010 and Low\u2010Concentration Formulations of Adalimumab Biosimilar\n                    <scp>ABP<\/scp>\n                    501, Adalimumab\u2010Atto"],"prefix":"10.1002","volume":"14","author":[{"given":"Vincent","family":"Chow","sequence":"first","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhan","family":"Zhou","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel T.","family":"Mytych","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Colbert","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mieke Jill","family":"Miller","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iwona","family":"Wala","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahad","family":"Sabet","sequence":"additional","affiliation":[{"name":"Icon  Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5254-7436","authenticated-orcid":false,"given":"Waldemar","family":"Radziszewski","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,3,19]]},"reference":[{"key":"e_1_2_13_2_1","unstructured":"EMA \u201cAmgevita: EPAR \u2010 Product Information \u201d(2017) https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/amgevita\u2010epar\u2010product\u2010information_en.pdf."},{"key":"e_1_2_13_3_1","unstructured":"FDA \u201cAMJEVITA (adalimumab\u2010atto) injection for subcutaneous use \u201d(2016) https:\/\/www.pi.amgen.com\/\u2010\/media\/Project\/Amgen\/Repository\/pi\u2010amgen\u2010com\/Amjevita\/amjevita_pi_hcp_english.pdf."},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2015.169"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/ard.61.suppl_2.ii70"},{"key":"e_1_2_13_6_1","unstructured":"FDA \u201cHumira: Prescribing Information \u201d(2002) https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/125057s417lbl.pdf."},{"key":"e_1_2_13_7_1","unstructured":"EMA \u201cHumira: EPAR\u2014Product Information; Annex I Summary of product characteristics \u201d(2025) https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/humira\u2010epar\u2010product\u2010information_en.pdf."},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40259\u2010016\u20100184\u20103"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis\u20102015\u2010208914"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis\u20102016\u2010210459"}],"container-title":["Pharmacology Research &amp; Perspectives"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/prp2.70236","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/prp2.70236","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/prp2.70236","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T03:46:13Z","timestamp":1780890373000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/prp2.70236"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,19]]},"references-count":9,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1002\/prp2.70236"],"URL":"https:\/\/doi.org\/10.1002\/prp2.70236","archive":["Portico"],"relation":{},"ISSN":["2052-1707","2052-1707"],"issn-type":[{"value":"2052-1707","type":"print"},{"value":"2052-1707","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,19]]},"assertion":[{"value":"2025-04-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70236"}}