{"id":"https://openalex.org/W47829030","doi":"https://doi.org/10.2165/00063030-200923010-00005","title":"Pharmacokinetic and Pharmacodynamic Profile of New Biosimilar Filgrastim XM02 Equivalent to Marketed Filgrastim Neupogen\u00ae","display_name":"Pharmacokinetic and Pharmacodynamic Profile of New Biosimilar Filgrastim XM02 Equivalent to Marketed Filgrastim Neupogen\u00ae","publication_year":2009,"publication_date":"2009-01-01","ids":{"openalex":"https://openalex.org/W47829030","doi":"https://doi.org/10.2165/00063030-200923010-00005","mag":"47829030","pmid":"https://pubmed.ncbi.nlm.nih.gov/19344191"},"language":"en","primary_location":{"id":"doi:10.2165/00063030-200923010-00005","doi":"https://doi.org/10.2165/00063030-200923010-00005","is_oa":false,"landing_page_url":"https://doi.org/10.2165/00063030-200923010-00005","pdf_url":null,"source":{"id":"https://openalex.org/S143194599","display_name":"BioDrugs","issn_l":"1172-7039","issn":["1172-7039","1173-8804","1179-190X","2195-8351"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1"],"host_organization":"https://openalex.org/P4310320330","host_organization_name":"Adis, Springer Healthcare","host_organization_lineage":["https://openalex.org/P4310320330","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Adis, Springer Healthcare","Springer Nature"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"BioDrugs","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5031256236","display_name":"Heinz Lubenau","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Heinz Lubenau","raw_affiliation_strings":["BioGeneriX AG, Mannheim, Germany. heinz.lubenau@t-online.de","BioGeneriX AG, Mannheim, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"BioGeneriX AG, Mannheim, Germany. heinz.lubenau@t-online.de","institution_ids":[]},{"raw_affiliation_string":"BioGeneriX AG, Mannheim, Germany","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5025919221","display_name":"Peter Bias","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Peter Bias","raw_affiliation_strings":["Merckle GmbH, Ulm, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Merckle GmbH, Ulm, Germany","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5025988496","display_name":"Anne-Katrin Maly","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Anne-Katrin Maly","raw_affiliation_strings":["BioGeneriX AG, Mannheim, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"BioGeneriX AG, Mannheim, Germany","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5006772870","display_name":"Karl Ernst Siegler","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210103903","display_name":"Clinical Research Services","ror":"https://ror.org/01c127k53","country_code":"DE","type":"healthcare","lineage":["https://openalex.org/I4210103903"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Karl Ernst Siegler","raw_affiliation_strings":["CRS-Mannheim GmbH, Gr\u00fcnstadt, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"CRS-Mannheim GmbH, Gr\u00fcnstadt, Germany","institution_ids":["https://openalex.org/I4210103903"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5051542429","display_name":"Kai Mehltretter","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210103903","display_name":"Clinical Research Services","ror":"https://ror.org/01c127k53","country_code":"DE","type":"healthcare","lineage":["https://openalex.org/I4210103903"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Kai Mehltretter","raw_affiliation_strings":["CRS-Mannheim GmbH, Mannheim, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"CRS-Mannheim GmbH, Mannheim, Germany","institution_ids":["https://openalex.org/I4210103903"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5031256236"],"corresponding_institution_ids":[],"apc_list":{"value":5190,"currency":"USD","value_usd":5190},"apc_paid":null,"fwci":2.1564,"has_fulltext":false,"cited_by_count":60,"citation_normalized_percentile":{"value":0.86806452,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":99},"biblio":{"volume":"23","issue":"1","first_page":"43","last_page":"51"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.9955999851226807,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.9955999851226807,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T12172","display_name":"Neutropenia and Cancer Infections","score":0.00279999990016222,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/filgrastim","display_name":"filgrastim","score":0.9229999780654907},{"id":"https://openalex.org/keywords/biosimilars","display_name":"biosimilars","score":0.8349999785423279},{"id":"https://openalex.org/keywords/granulocyte-colony-stimulating-factor","display_name":"granulocyte colony-stimulating factor","score":0.925000011920929},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.7680000066757202},{"id":"https://openalex.org/keywords/pharmacodynamics","display_name":"pharmacodynamics","score":0.9950000047683716},{"id":"https://openalex.org/keywords/bioequivalence","display_name":"bioequivalence","score":0.9750000238418579},{"id":"https://openalex.org/keywords/cd34-cells","display_name":"CD34+ cells","score":0.8009999990463257},{"id":"https://openalex.org/keywords/absolute-neutrophil-count","display_name":"absolute neutrophil count","score":0.8709999918937683},{"id":"https://openalex.org/keywords/neutropenia","display_name":"neutropenia","score":0.878000020980835},{"id":"https://openalex.org/keywords/stem-cell-mobilization","display_name":"stem cell mobilization","score":0.9819999933242798},{"id":"https://openalex.org/keywords/subcutaneous-administration","display_name":"subcutaneous administration","score":0.675000011920929},{"id":"https://openalex.org/keywords/intravenous-infusion","display_name":"intravenous infusion","score":0.8519999980926514},{"id":"https://openalex.org/keywords/escherichia-coli-expression","display_name":"Escherichia coli expression","score":0.7059999704360962}],"concepts":[{"id":"https://openalex.org/C2779171977","wikidata":"https://www.wikidata.org/wiki/Q3151081","display_name":"Filgrastim","level":4,"score":0.9851848483085632},{"id":"https://openalex.org/C59491497","wikidata":"https://www.wikidata.org/wiki/Q864715","display_name":"Biosimilar","level":2,"score":0.8023194074630737},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.7351199984550476},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.6808899641036987},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.6704449653625488},{"id":"https://openalex.org/C111113717","wikidata":"https://www.wikidata.org/wiki/Q725307","display_name":"Pharmacodynamics","level":3,"score":0.6218598484992981},{"id":"https://openalex.org/C2777767877","wikidata":"https://www.wikidata.org/wiki/Q419327","display_name":"Granulocyte colony-stimulating factor","level":3,"score":0.616205096244812},{"id":"https://openalex.org/C22979827","wikidata":"https://www.wikidata.org/wiki/Q5137311","display_name":"Cmax","level":3,"score":0.47075989842414856},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.2978571653366089},{"id":"https://openalex.org/C2776694085","wikidata":"https://www.wikidata.org/wiki/Q974135","display_name":"Chemotherapy","level":2,"score":0.14576929807662964}],"mesh":[{"descriptor_ui":"D000069585","descriptor_name":"Filgrastim","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000293","descriptor_name":"Adolescent","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000328","descriptor_name":"Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002465","descriptor_name":"Cell Movement","qualifier_ui":"Q000187","qualifier_name":"drug effects","is_major_topic":true},{"descriptor_ui":"D002626","descriptor_name":"Chemistry, Pharmaceutical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005858","descriptor_name":"Germany","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007262","descriptor_name":"Infusions, Intravenous","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007279","descriptor_name":"Injections, Subcutaneous","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007958","descriptor_name":"Leukocyte Count","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008297","descriptor_name":"Male","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008875","descriptor_name":"Middle Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D009504","descriptor_name":"Neutrophils","qualifier_ui":"Q000187","qualifier_name":"drug effects","is_major_topic":true},{"descriptor_ui":"D011994","descriptor_name":"Recombinant Proteins","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013234","descriptor_name":"Stem Cells","qualifier_ui":"Q000187","qualifier_name":"drug effects","is_major_topic":true},{"descriptor_ui":"D013234","descriptor_name":"Stem Cells","qualifier_ui":"Q000276","qualifier_name":"immunology","is_major_topic":false},{"descriptor_ui":"D013810","descriptor_name":"Therapeutic Equivalency","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016037","descriptor_name":"Single-Blind Method","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016179","descriptor_name":"Granulocyte Colony-Stimulating Factor","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":true},{"descriptor_ui":"D016179","descriptor_name":"Granulocyte Colony-Stimulating Factor","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D016179","descriptor_name":"Granulocyte Colony-Stimulating Factor","qualifier_ui":"Q000097","qualifier_name":"blood","is_major_topic":false},{"descriptor_ui":"D016179","descriptor_name":"Granulocyte Colony-Stimulating Factor","qualifier_ui":"Q000493","qualifier_name":"pharmacokinetics","is_major_topic":true},{"descriptor_ui":"D018592","descriptor_name":"Cross-Over Studies","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018952","descriptor_name":"Antigens, CD34","qualifier_ui":"Q000032","qualifier_name":"analysis","is_major_topic":false},{"descriptor_ui":"D019650","descriptor_name":"Hematopoietic Stem Cell Mobilization","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D055815","descriptor_name":"Young Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.2165/00063030-200923010-00005","doi":"https://doi.org/10.2165/00063030-200923010-00005","is_oa":false,"landing_page_url":"https://doi.org/10.2165/00063030-200923010-00005","pdf_url":null,"source":{"id":"https://openalex.org/S143194599","display_name":"BioDrugs","issn_l":"1172-7039","issn":["1172-7039","1173-8804","1179-190X","2195-8351"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1"],"host_organization":"https://openalex.org/P4310320330","host_organization_name":"Adis, Springer Healthcare","host_organization_lineage":["https://openalex.org/P4310320330","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Adis, Springer Healthcare","Springer Nature"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"BioDrugs","raw_type":"journal-article"},{"id":"pmid:19344191","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/19344191","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy","raw_type":"Clinical Trial, Phase I"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.9537000060081482,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[{"id":"https://openalex.org/study-designs/clinical-trial","display_name":"Clinical Trial"}],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":17,"referenced_works":["https://openalex.org/W109252363","https://openalex.org/W115856346","https://openalex.org/W816475082","https://openalex.org/W1532162953","https://openalex.org/W1969369083","https://openalex.org/W1990584440","https://openalex.org/W2018531137","https://openalex.org/W2042418092","https://openalex.org/W2046428819","https://openalex.org/W2066689114","https://openalex.org/W2072989565","https://openalex.org/W2086682597","https://openalex.org/W2118168943","https://openalex.org/W2118800567","https://openalex.org/W2155325844","https://openalex.org/W2400112015","https://openalex.org/W2409693554"],"related_works":["https://openalex.org/W2886203450","https://openalex.org/W1899458195","https://openalex.org/W2163894227","https://openalex.org/W3080627480","https://openalex.org/W1968659034","https://openalex.org/W2036684015","https://openalex.org/W2188792951","https://openalex.org/W1889262944","https://openalex.org/W4382011406","https://openalex.org/W2088008670"],"abstract_inverted_index":null,"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":1},{"year":2022,"cited_by_count":1},{"year":2021,"cited_by_count":1},{"year":2020,"cited_by_count":2},{"year":2019,"cited_by_count":3},{"year":2018,"cited_by_count":9},{"year":2017,"cited_by_count":3},{"year":2016,"cited_by_count":6},{"year":2015,"cited_by_count":6},{"year":2014,"cited_by_count":4},{"year":2013,"cited_by_count":7},{"year":2012,"cited_by_count":6}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}
