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Centering on pharmacokinetic comparability for biologics, this manuscript summarizes current and emerging insights drawing from a webinar hosted by the American Society for Clinical Pharmacology and Therapeutics Life Cycle Management Community. The common theme across industry and regulatory experiences is the use of risk\u2010based, hierarchical approaches to bridge pre\u2010 and post\u2010change products, ranging from foundational analytical comparability to clinical pharmacokinetic comparability studies.<\/jats:p>","DOI":"10.1002\/cpt.70480","type":"journal-article","created":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T12:36:05Z","timestamp":1789648565000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Perspective on Pharmacokinetic Comparability for Biologics Development"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4517-7569","authenticated-orcid":false,"given":"Fei","family":"Tang","sequence":"first","affiliation":[{"name":"Genentech, Inc. South San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-6517-7160","authenticated-orcid":false,"given":"Yifei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (OCP\/CDER\/FDA) Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9825-5890","authenticated-orcid":false,"given":"Mohamed","family":"Elmeliegy","sequence":"additional","affiliation":[{"name":"Pfizer, Inc. San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8673-1327","authenticated-orcid":false,"given":"Janki Mihir","family":"Desai","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie, Inc. 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Pharm. Sci."},{"key":"e_1_2_9_4_1","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1007\/s11095-023-03627-5","article-title":"A survey of FDA approved monoclonal antibodies and fc\u2010fusion proteins for manufacturing changes and comparability assessment","volume":"41","author":"Li Z.","year":"2024","journal-title":"Pharm. Res."},{"key":"e_1_2_9_5_1","volume-title":"Bridging for Drug\u2010Device and Biologic\u2010Device Combination Products: Guidance for Industry","year":"2019"},{"key":"e_1_2_9_6_1","doi-asserted-by":"crossref","first-page":"404","DOI":"10.1002\/cpt.3145","article-title":"Pharmacokinetics\u2010bridging between autoinjectors and prefilled syringes for subcutaneous injection: case examples revealing a knowledge gap","volume":"115","author":"Li Z.","year":"2024","journal-title":"Clin. Pharmacol. Ther."},{"key":"e_1_2_9_7_1","volume-title":"Qualification opinion for Molecule\u2010independent device bridging approach (MIDBA)","year":"2026"},{"key":"e_1_2_9_8_1","doi-asserted-by":"crossref","first-page":"28","DOI":"10.1002\/cpt.70283","article-title":"Insights into PK\u2010based bridging for products using a common autoinjector platform: a review of 16 autoinjectors in 14 biological license applications","volume":"120","author":"Li Z.","year":"2026","journal-title":"Clin. Pharmacol. 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