{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T13:01:49Z","timestamp":1790341309240,"version":"4.1.0"},"reference-count":29,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T00:00:00Z","timestamp":1788393600000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Bioequivalence and safety of ADL\u2010018, an omalizumab biosimilar, were compared with United States\u2010licensed omalizumab (US\u2010OMA) and European Union\u2010approved omalizumab (EU\u2010OMA), both approved for allergies. Healthy adults were randomized (1:1:1) to receive a dose of ADL\u2010018, US\u2010OMA, or EU\u2010OMA (150 mg\/mL). Pharmacokinetic (PK) parameters, including AUC\n                    <jats:sub>(0\u2013last)<\/jats:sub>\n                    , AUC\n                    <jats:sub>(0\u2013\u221e)<\/jats:sub>\n                    , and C\n                    <jats:sub>max<\/jats:sub>\n                    , were considered equivalent if 90% CIs of geometric mean ratios (GMRs) were within predefined equivalence margin (0.80\u20131.25) using ANCOVA model. Other PK parameters, pharmacodynamics (PD) (free\/total immunoglobulin E [IgE]), immunogenicity, and safety were compared. Overall, 306 participants (n\u00a0=\u00a0102 per arm) were dosed; 287 completed the study. Equivalence of primary PK parameters was confirmed for pairwise comparisons, with 90% CIs within the predefined margin (GMRs of ADL\u2010018 vs US\u2010OMA: AUC\n                    <jats:sub>(0\u2013last)<\/jats:sub>\n                    \u20141.08, AUC\n                    <jats:sub>(0\u2013\u221e)<\/jats:sub>\n                    \u20141.07, C\n                    <jats:sub>max<\/jats:sub>\n                    \u20141.05; GMRs of ADL\u2010018 vs EU\u2010OMA: AUC\n                    <jats:sub>(0\u2013last)<\/jats:sub>\n                    \u20141.06, AUC\n                    <jats:sub>(0\u2013\u221e)<\/jats:sub>\n                    \u20141.06, C\n                    <jats:sub>max<\/jats:sub>\n                    \u2013 1.05; and GMRs of US\u2010OMA vs EU\u2010OMA: AUC\n                    <jats:sub>(0\u2013last)<\/jats:sub>\n                    \u20140.99, AUC\n                    <jats:sub>(0\u2013\u221e)<\/jats:sub>\n                    \u20140.99, C\n                    <jats:sub>max<\/jats:sub>\n                    \u20141.00). PK\/PD parameters were comparable across arms. Increase in total IgE (AUEC \u223c30,000 to 35,000 h IU\/mL) and decrease in free IgE (AUEC \u223c29,000 to 35,000 h IU\/mL) were comparable across arms. Similar incidence of adverse events across arms (treatment\u2010emergent adverse events: ADL\u2010018, n\u00a0=\u00a06; US\u2010OMA, n\u00a0=\u00a05; EU\u2010OMA, n\u00a0=\u00a04) was observed. ADL\u2010018 demonstrated PK\/PD equivalence and comparable safety profile to reference omalizumab.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70098","type":"journal-article","created":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T07:07:08Z","timestamp":1788419228000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic and Pharmacodynamic Bio\u2010Similarity of ADL\u2010018 to Innovator Omalizumab: A Randomized Study in Healthy Adults"],"prefix":"10.1002","volume":"15","author":[{"given":"Sunil","family":"Soitawala","sequence":"first","affiliation":[{"name":"Clinical Research Department Veeda Clinical Research Ltd.  Mehsana Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiren","family":"Prajapati","sequence":"additional","affiliation":[{"name":"Clinical Research Department Veeda Clinical Research Ltd.  Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiren","family":"Mehta","sequence":"additional","affiliation":[{"name":"Clinical Affairs\/Biometrics Department Veeda Clinical Research Ltd.  Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pawan Kumar","family":"Singh","sequence":"additional","affiliation":[{"name":"Kashiv Biosciences, LLC  Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,3]]},"reference":[{"issue":"3","key":"e_1_2_11_2_1","first-page":"223","article-title":"Efficacy and safety of omalizumab in patients with moderate\u2010to\u2010severe asthma: an analytic comparison of data from randomized controlled trials between Chinese and Caucasians","volume":"40","author":"Li J","year":"2022","journal-title":"Asian Pac J Allergy Immunol"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.alit.2020.01.004"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2023.03.055"},{"key":"e_1_2_11_5_1","volume-title":"Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry","author":"US Food and Drug Administration","year":"2015"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2021.11.009"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.14494"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2024.06.023"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vhri.2013.01.007"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2024.10.1468"},{"key":"e_1_2_11_11_1","unstructured":"Celltrion receives European Commission approval of omlyclo (CT\u2010P39) the first and only omalizumab biosimilar approved in Europe. May 24 2025. Accessed July 14 2025.https:\/\/celltrion.com\/en\u2010us\/company\/media\u2010center\/press\u2010release\/3246."},{"key":"e_1_2_11_12_1","unstructured":"JeremiasS.FDA approves first omalizumab biosimilar. The Center for Biosimilars. March 7 2025. Accessed Jun 25 2025.https:\/\/www.centerforbiosimilars.com\/view\/fda\u2010approves\u2010first\u2010omalizumab\u2010biosimilar"},{"key":"e_1_2_11_13_1","unstructured":"JeremiasS.Health Canada approves first omalizumab biosimilar. The Center for Biosimilars\u00ae. December 16 2025. Accessed Jun 25 2025.https:\/\/www.centerforbiosimilars.com\/view\/health\u2010canada\u2010approves\u2010first\u2010omalizumab\u2010biosimilar."},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.4172\/jbb.1000075"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1373"},{"key":"e_1_2_11_16_1","unstructured":"Kashiv BioSciences ADL\u2010018 Investigator's Brochure Edition 06 20 Dec 2024 (unpublished)."},{"key":"e_1_2_11_17_1","volume-title":"Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials","author":"FDA Guidance for Industry","year":"2007"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/clt2.12204"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1080\/1750743X.2025.2467026"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.2332\/allergolint.13-OA-0643"},{"issue":"5","key":"e_1_2_11_21_1","first-page":"3497","article-title":"Enhanced sensitivity of capture IgE\u2010ELISA based on a recombinant Der f 1\/2 fusion protein for the detection of IgE antibodies targeting house dust mite allergens","volume":"19","author":"Zhang Z","year":"2019","journal-title":"Mol Med Rep"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jim.2005.06.008"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009705"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2020.05.032"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13223-020-00442-0"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13223-019-0380-z"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1177\/20587384211065870"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2004.00770.x"},{"issue":"3","key":"e_1_2_11_29_1","first-page":"223","article-title":"Efficacy and safety of omalizumab in patients with moderate\u2010to\u2010severe asthma: an analytic comparison of data from randomized controlled trials between Chinese and Caucasians","volume":"40","author":"Li J","year":"2022","journal-title":"Asian Pac J Allergy Immunol"},{"key":"e_1_2_11_30_1","unstructured":"Study to compare efficacy safety and immunogenicity of ADL\u2010018 with XOLAIR (omalizumab) in adults with chronic idiopathic urticaria. 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