{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T18:11:21Z","timestamp":1788459081221,"version":"build-2803163510"},"reference-count":24,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,2,22]],"date-time":"2024-02-22T00:00:00Z","timestamp":1708560000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Omalizumab is an anti\u2010IgE monoclonal antibody currently approved for the treatment of asthma, nasal polyps\/chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. Omalizumab is available as an injection in a prefilled syringe (PFS) with a needle safety device (NSD). New product configurations were developed to reduce the number of injections per dose administration, improve patient convenience and treatment compliance. The objective of this randomized open\u2010label 12\u2010week study was to demonstrate pharmacokinetic bioequivalence between (1) new PFS with autoinjector (PFS\u2010AI), (2) new PFS\u2010NSD configuration, and (3) current PFS\u2010NSD configuration. Each new configuration was considered bioequivalent to the current configuration if the confidence intervals (CIs) for the geometric mean ratios (GMR) were contained in the 0.80\u20101.25 range for maximum concentration (C<jats:sub>max<\/jats:sub>), area under the concentration\u2010time curve until the last quantifiable measurement (AUC<jats:sub>last<\/jats:sub>), and AUC extrapolated to infinity (AUC<jats:sub>inf<\/jats:sub>). Safety was assessed throughout the study. In total, 193 healthy volunteers were randomized at 1:1:1 ratio to omalizumab 1\u00d7300\u00a0mg\/2\u00a0mL via new PFS\u2010AI (n = 66), omalizumab 1\u00d7300\u00a0mg\/2\u00a0mL via new PFS\u2010NSD (n = 64), or omalizumab 2\u00d7150\u00a0mg\/1\u00a0mL via current PFS\u2010NSD (n = 63). Comparing new PFS\u2010AI versus current PFS\u2010NSD, the GMRs were: C<jats:sub>max<\/jats:sub>, 1.085; AUC<jats:sub>last<\/jats:sub>, 1.093; AUC<jats:sub>inf<\/jats:sub>, 1.100. Comparing new PFS\u2010NSD versus current PFS\u2010NSD, the GMRs were: C<jats:sub>max<\/jats:sub>, 1.006; AUC<jats:sub>last<\/jats:sub>, 1.016; AUC<jats:sub>inf<\/jats:sub>, 1.027. The 95% CIs for all GMR parameters were contained within the 0.80\u20101.25 range. Safety findings were consistent with the known safety profile of omalizumab. Single\u2010dose omalizumab administered as the new PFS\u2010AI or new PFS\u2010NSD was bioequivalent to the current PFS\u2010NSD.<\/jats:p>","DOI":"10.1002\/cpdd.1373","type":"journal-article","created":{"date-parts":[[2024,2,23]],"date-time":"2024-02-23T06:33:46Z","timestamp":1708670026000},"page":"611-620","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Bioequivalence Between a New Omalizumab Prefilled Syringe With an Autoinjector or with a Needle Safety Device Compared with the Current Prefilled Syringe: A Randomized Controlled Trial in Healthy Volunteers"],"prefix":"10.1002","volume":"13","author":[{"given":"Ramachandra","family":"Sangana","sequence":"first","affiliation":[{"name":"Novartis Institutes for Biomedical Research  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Xu","sequence":"additional","affiliation":[{"name":"Genentech Research and Early 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