A demonstration of analytical similarity comparing a proposed biosimilar pegfilgrastim and reference pegfilgrastim

Welte, 1985, Purification and biochemical characterization of human pluripotent hematopoietic colony-stimulating factor, Proc Natl Acad Sci U. S. A, 82, 1526, 10.1073/pnas.82.5.1526 Souza, 1986, Recombinant human granulocyte colony-stimulating factor: effects on normal and leukemic myeloid cells, Science, 232, 61, 10.1126/science.2420009 Bodey, 1966, Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia, Ann Intern Med, 64, 328, 10.7326/0003-4819-64-2-328 Crawford, 2004, Chemotherapy-induced neutropenia: risks, consequences, and new directions for its management, Cancer, 100, 228, 10.1002/cncr.11882 Leonard, 2003, Impact of neutropenia on delivering planned adjuvant chemotherapy: UK audit of primary breast cancer patients, Br J Cancer, 89, 2062, 10.1038/sj.bjc.6601279 Lyman, 2003, Risk of febrile neutropenia among patients with intermediate-grade non-Hodgkin's lymphoma receiving CHOP chemotherapy, Leuk Lymphoma, 44, 2069, 10.1080/1042819031000119262 Kinstler, 1996, Characterization and stability of N-terminally PEGylated rhG-CSF, Pharm Res, 13, 996, 10.1023/A:1016042220817 Molineux, 2004, The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta), Curr Pharm Des, 10, 1235, 10.2174/1381612043452613 Curran, 2002, Pegfilgrastim Drugs, 62, 1207, 10.2165/00003495-200262080-00012 Office of the Legislative Counsel: U.S. House of Representatives, 2013 2015 2015 Bagal, 2008, Gas-phase proton-transfer chemistry coupled with TOF mass spectrometry and ion mobility-MS for the facile analysis of poly(ethylene glycols) and PEGylated polypeptide conjugates, Anal Chem, 80, 2408, 10.1021/ac7020163 Forstenlehner, 2014, Direct-infusion- and HPLC-ESI-orbitrap-MS approach for the characterization of intact PEGylated proteins, Anal Chem, 86, 826, 10.1021/ac403390y Yan, 2004, Mass spectrometric approaches using electrospray ionization charge states and hydrogen-deuterium exchange for determining protein structures and their conformational changes, Mol Cell Proteomics, 3, 10, 10.1074/mcp.R300010-MCP200 United States pharmacopeia and national Formulary (USP 40-NF 35). vol. 2. Rockville, MD: United States Pharmacopeia Convention; 2017:4196–4201. Desai, 2016, Confirmation of biosimilarity in a pharmacokinetic/pharmacodynamic study in healthy volunteers for an analytically highly similar pegfilgrastim, Clin Pharmacol Drug Dev, 5, 354, 10.1002/cpdd.269