{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T13:02:42Z","timestamp":1784638962635,"version":"3.55.0"},"reference-count":24,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T00:00:00Z","timestamp":1783468800000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Addition of polyethylene glycol (PEG), or PEGylation, is a modification that extends the half\u2010life of drug products, thereby reducing the frequency of dosing. However, PEGylation can pose challenges for biosimilar drug development, as replicating the reference product's PEG characteristics to achieve similarity to the reference product's pharmacokinetics (PK) can be difficult. A few biosimilar product submissions have highlighted issues with PK assays, potentially contributing to failures in PK similarity assessment. With many approved PEGylated protein therapeutics soon becoming eligible for biosimilar development, developing alternative methods for PK assessment that can be applied across multiple product categories may help to facilitate a more efficient biosimilar development program. We previously validated an ELISA\u2010based method and observed significant variability even in samples prepared with known drug concentrations. We decided that a cell\u2010based assay (CBA) might offer greater translatability to other PEGylated products. CBAs rely on cells with receptors for the drug product being tested, and the choice of cell line would vary depending on the specific drug product. In this study, we utilized pegfilgrastim, a PEGylated granulocyte\u2010colony stimulating factor (G\u2010CSF) product, for PK determination using the CBA method. This proof\u2010of\u2010concept study demonstrates that while the sensitivity of the CBA is lower than that of the validated ELISA, its ability to capture receptor\u2010accessible drug provides an important advantage for pharmacokinetic assessment. Moreover, it exhibits good reproducibility and can be read using a 96\u2010well platform. This CBA approach may be a viable option for the rapid development of PK assays for other PEGylated drug products.<\/jats:p>","DOI":"10.1111\/cts.70588","type":"journal-article","created":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T03:38:13Z","timestamp":1783568293000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Advancing\n                    <scp>PEGylated<\/scp>\n                    Drug Evaluation: A Novel Approach to Pegfilgrastim Pharmacokinetic Assessment"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5320-0098","authenticated-orcid":false,"given":"Elizaveta","family":"Svyatova","sequence":"first","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food &amp; Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-1083-696X","authenticated-orcid":false,"given":"Da","family":"Shi","sequence":"additional","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food &amp; Drug Administration  Silver Spring Maryland USA"},{"name":"Division of Health Technology V\u2010A, Office of Health Technology V, Office of Product Evaluation and Quality Center for Devices and Radiological Health, U.S. Food &amp; Drug Administration  Silver Spring USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9771-8777","authenticated-orcid":false,"given":"Ankit","family":"Shah","sequence":"additional","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food &amp; Drug Administration  Silver Spring Maryland USA"},{"name":"Division of Cancer Pharmacology I, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food &amp; Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8891-754X","authenticated-orcid":false,"given":"Kristina E.","family":"Howard","sequence":"additional","affiliation":[{"name":"Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, U.S. Food &amp; Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,8]]},"reference":[{"issue":"9","key":"e_1_2_8_2_1","article-title":"Trends and Perspectives of Biological Drug Approvals by the FDA: A Review From 2015 to 2021","volume":"10","author":"Martins A. 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