{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T11:55:51Z","timestamp":1768823751576,"version":"3.49.0"},"reference-count":22,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2024,6,1]],"date-time":"2024-06-01T00:00:00Z","timestamp":1717200000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2024,7,3]],"date-time":"2024-07-03T00:00:00Z","timestamp":1719964800000},"content-version":"vor","delay-in-days":32,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs R D"],"published-print":{"date-parts":[[2024,6]]},"DOI":"10.1007\/s40268-024-00471-9","type":"journal-article","created":{"date-parts":[[2024,7,3]],"date-time":"2024-07-03T13:03:09Z","timestamp":1720011789000},"page":"285-301","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Demonstration of Physicochemical and Functional Similarity of Biosimilar Pegfilgrastim-cbqv to Pegfilgrastim"],"prefix":"10.1007","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9802-9033","authenticated-orcid":false,"given":"Henriette","family":"Kuehne","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janice M.","family":"Davis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"LeeAnne","family":"Merewether","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"McQueen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth","family":"Valentine","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-4105-8721","authenticated-orcid":false,"given":"Glen","family":"Young","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin T.","family":"Andrews","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dimitri","family":"Diaz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-8125-7187","authenticated-orcid":false,"given":"Karen J.","family":"Miller","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,7,3]]},"reference":[{"key":"471_CR1","doi-asserted-by":"publisher","first-page":"329","DOI":"10.37765\/ajmc.2022.88809","volume":"28","author":"A Mulcahy","year":"2022","unstructured":"Mulcahy A, Buttorff C, Finegold K, El-Kilani Z, Oliver JF, Murphy S, Jessup A. Projected US savings from biosimilars, 2021\u20132025. Am J Manag Care. 2022;28:329\u201335. https:\/\/doi.org\/10.37765\/ajmc.2022.88809.","journal-title":"Am J Manag Care"},{"key":"471_CR2","unstructured":"US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/scientific-considerations-demonstrating-biosimilarity-reference-product Accessed 15 Mar 2024."},{"key":"471_CR3","unstructured":"US Food and Drug Administration. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. Guidance for industry. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/quality-considerations-demonstrating-biosimilarity-therapeutic-protein-product-reference-product Accessed 15 Mar 2024."},{"key":"471_CR4","unstructured":"US Food and Drug Administration. Development of therapeutic protein biosimilars: comparative analytical assessment and other quality-related considerations. Guidance for industry. https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/development-therapeutic-protein-biosimilars-comparative-analytical-assessment-and-other-quality. Accessed 15 Mar 2024"},{"key":"471_CR5","unstructured":"Coherus Biosciences. UDENYCA\u00ae sales data up to October 2023."},{"key":"471_CR6","unstructured":"Cost comparison of Wholesale Acquisition Cost (WAC) for UDENYCA\u00ae https:\/\/assets.website-files.com\/655b7369762c6bc9dc66f15d\/659de0550bbf83eebcc53291_doc-product-fact-sheet.pdf Accessed 18 Mar 2024 and Neulasta\u00ae https:\/\/www.neulasta.com\/paying-for-neulasta. Accessed 18 Mar 2024."},{"key":"471_CR7","unstructured":"Coherus Biosciences Inc. FDA Approves UDENYCA\u00ae Autoinjector. In: FDA Approves UDENYCA\u00ae Autoinjector. 2023. https:\/\/investors.coherus.com\/news-releases\/news-release-details\/fda-approves-udenycar-autoinjector. Accessed 15 Mar 2024."},{"key":"471_CR8","unstructured":"Coherus Biosciences. Coherus announces FDA approval of UDENYCA ONBODY\u2122, a novel and proprietary state-of-the-art delivery system for pegfilgrastim-cbqv. 2024. https:\/\/investors.coherus.com\/news-releases\/news-release-details\/coherus-announces-us-launch-udenyca-onbodytm-novel-and Accessed 15 Mar 2024."},{"key":"471_CR9","doi-asserted-by":"publisher","first-page":"4291","DOI":"10.1007\/s12325-020-01459-y","volume":"37","author":"B Finck","year":"2020","unstructured":"Finck B, Tang H, Civoli F, Hodge J, O\u2019Kelly H, Vexler V. Pharmacokinetic and pharmacodynamic equivalence of pegfilgrastim-cbqv and pegfilgrastim in healthy subjects. Adv Ther. 2020;37:4291\u2013307. https:\/\/doi.org\/10.1007\/s12325-020-01459-y.","journal-title":"Adv Ther"},{"key":"471_CR10","doi-asserted-by":"publisher","first-page":"1230","DOI":"10.1007\/s12325-021-02024-x","volume":"39","author":"F Civoli","year":"2022","unstructured":"Civoli F, Finck B, Tang H, Hodge J, O\u2019Kelly H, Vexler V. Biosimilar pegfilgrastim-cbqv demonstrated similar immunogenicity to pegfilgrastim in healthy subjects across three randomized clinical studies. Adv Ther. 2022;39:1230\u201346. https:\/\/doi.org\/10.1007\/s12325-021-02024-x.","journal-title":"Adv Ther"},{"issue":"2","key":"471_CR11","doi-asserted-by":"publisher","first-page":"197","DOI":"10.1080\/10543406.2016.1272606","volume":"27","author":"Y Tsong","year":"2017","unstructured":"Tsong Y, Dong X, Shen M. Development of statistical methods for analytical similarity assessment. J Biopharm Stats. 2017;27(2):197\u2013205. https:\/\/doi.org\/10.1080\/10543406.2016.1272606.","journal-title":"J Biopharm Stats."},{"key":"471_CR12","doi-asserted-by":"publisher","first-page":"567","DOI":"10.1021\/ac801711u","volume":"81","author":"L Huang","year":"2009","unstructured":"Huang L. Characterization of poly(ethylene glycol) and PEGylated products by LC\/MS with postcolumn addition of amines. Anal Chem. 2009;81:567\u201377.","journal-title":"Anal Chem"},{"key":"471_CR13","doi-asserted-by":"publisher","first-page":"826","DOI":"10.1021\/ac403390y","volume":"86","author":"IC Forstenlehner","year":"2014","unstructured":"Forstenlehner IC, Holzmann J, Scheffler K, Wieder W, Toll H, Huber CG. A direct-infusion- and HPLC-ESI-Orbitrap-MS approach for the characterization of intact PEGylated proteins. Anal Chem. 2014;86:826\u201334. https:\/\/doi.org\/10.1021\/ac403390y.","journal-title":"Anal Chem"},{"key":"471_CR14","doi-asserted-by":"publisher","first-page":"115","DOI":"10.1007\/978-3-662-03910-6_8","volume-title":"Size exclusion chromatography. Molecular-weight-sensitive detectors","author":"S Mori","year":"1999","unstructured":"Mori S, Bath HG. Molecular-weight-sensitive detectors. In: Size exclusion chromatography. Molecular-weight-sensitive detectors. Berlin: Springer; 1999. p. 115\u201329."},{"key":"471_CR15","doi-asserted-by":"publisher","first-page":"1822","DOI":"10.1023\/a:1011945704248","volume":"15","author":"PI Guerra","year":"1998","unstructured":"Guerra PI, Acklin C, Kosky AA, Davis JM, Treuheit MJ, Brems DN. PEGylation prevents the N-terminal degradation of megakaryocyte growth and development factor. Pharm Res. 1998;15:1822\u20137. https:\/\/doi.org\/10.1023\/a:1011945704248.","journal-title":"Pharm Res"},{"key":"471_CR16","doi-asserted-by":"publisher","first-page":"185","DOI":"10.1007\/s40259-015-0127-4","volume":"29","author":"T Arvedson","year":"2015","unstructured":"Arvedson T, O\u2019Kelly J, Yang BB. Design rationale and development approach for pegfilgrastim as a long-acting granulocyte colony-stimulating factor. BioDrugs. 2015;29:185\u201398. https:\/\/doi.org\/10.1007\/s40259-015-0127-4.","journal-title":"BioDrugs"},{"key":"471_CR17","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1006\/abbi.1998.1022","volume":"362","author":"HS Lu","year":"1999","unstructured":"Lu HS, Fausset PR, Narhi LO, Horan T, Shinagawa K, Shimamoto G, Boone TC. Chemical modification and site-directed mutagenesis of methionine residues in recombinant human granulocyte colony-stimulating factor: effect on stability and biological activity. Arch Biochem Biophys. 1999;362:1\u201311. https:\/\/doi.org\/10.1006\/abbi.1998.1022.","journal-title":"Arch Biochem Biophys"},{"key":"471_CR18","doi-asserted-by":"publisher","first-page":"6667","DOI":"10.1007\/s00216-013-7138-0","volume":"405","author":"J Holzmann","year":"2013","unstructured":"Holzmann J, Hausberger A, Rupprechter A, Toll H. Top-down MS for rapid methionine oxidation site assignment in filgrastim. Anal Bioanal Chem. 2013;405:6667\u201374. https:\/\/doi.org\/10.1007\/s00216-013-7138-0.","journal-title":"Anal Bioanal Chem"},{"key":"471_CR19","doi-asserted-by":"publisher","first-page":"13032","DOI":"10.1021\/acs.analchem.9b03127","volume":"91","author":"DL Riggs","year":"2019","unstructured":"Riggs DL, Silzel JW, Lyon YA, Kang AS, Julian RR. Analysis of glutamine deamidation: products, pathways, and kinetics. Anal Chem. 2019;91:13032\u20138. https:\/\/doi.org\/10.1021\/acs.analchem.9b03127.","journal-title":"Anal Chem"},{"key":"471_CR20","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0212622","volume":"14","author":"R Shekhawat","year":"2019","unstructured":"Shekhawat R, Shah CK, Patel A, Srinivasan S, Kapoor P, Patel S, Kumar S, Sonar S, More N, Joshi M, et al. Structural similarity, characterization of poly ethylene glycol linkage and identification of product related variants in biosimilar pegfilgrastim. PLoS ONE. 2019;14: e0212622. https:\/\/doi.org\/10.1371\/journal.pone.0212622.","journal-title":"PLoS ONE"},{"key":"471_CR21","doi-asserted-by":"publisher","first-page":"728","DOI":"10.34172\/apb.2021.082","volume":"11","author":"P Akbarzadehlaleh","year":"2021","unstructured":"Akbarzadehlaleh P, Mirzaei M, Mashahdi-Keshtiban M, Heidari HR. The effect of length and structure of attached polyethylene glycol chain on hydrodynamic radius, and separation of PEGylated human serum albumin by chromatography. Adv Pharm Bull. 2021;11:728\u201338. https:\/\/doi.org\/10.34172\/apb.2021.082.","journal-title":"Adv Pharm Bull."},{"key":"471_CR22","first-page":"278","volume-title":"Contributions to probability and statistics. Robust tests for equality of variances. Essays in Honor of Harold Hotelling","author":"H Levene","year":"1960","unstructured":"Levene H. Robust tests for equality of variances. In: Olkin I, Ghurye S, Hoeffding W, Madow WG, Mann HB, editors. Contributions to probability and statistics. Robust tests for equality of variances. Essays in Honor of Harold Hotelling. Stanford: Stanford University Press; 1960. p. 278\u201392."}],"container-title":["Drugs in R&amp;D"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40268-024-00471-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40268-024-00471-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40268-024-00471-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,9]],"date-time":"2024-08-09T10:28:35Z","timestamp":1723199315000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40268-024-00471-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6]]},"references-count":22,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,6]]}},"alternative-id":["471"],"URL":"https:\/\/doi.org\/10.1007\/s40268-024-00471-9","relation":{},"ISSN":["1174-5886","1179-6901"],"issn-type":[{"value":"1174-5886","type":"print"},{"value":"1179-6901","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6]]},"assertion":[{"value":"6 June 2024","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 July 2024","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was funded by Coherus BioSciences, Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"All authors except M.M., E.V., B.A., and D.D. are current employees of Coherus BioSciences. At the time of the study, all authors were employees of Coherus BioSciences.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"Data have been provided in Supplemental Materials. Coherus BioSciences will review all requests for additional data and consider providing those on a case-by-case basis.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data Availability Statement"}},{"value":"The main text of the paper was written by H.K., J.D., and K.M. All authors contributed to the collection and analysis of data. All authors reviewed and approved the final manuscript.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}}]}}