{"id":"https://openalex.org/W1971785230","doi":"https://doi.org/10.1038/clpt.2009.249","title":"Assessing the Safety and Comparative Effectiveness of Follow-On Biologics (Biosimilars) in the United States","display_name":"Assessing the Safety and Comparative Effectiveness of Follow-On Biologics (Biosimilars) in the United States","publication_year":2010,"publication_date":"2010-01-28","ids":{"openalex":"https://openalex.org/W1971785230","doi":"https://doi.org/10.1038/clpt.2009.249","mag":"1971785230","pmid":"https://pubmed.ncbi.nlm.nih.gov/20107450"},"language":"en","primary_location":{"id":"doi:10.1038/clpt.2009.249","doi":"https://doi.org/10.1038/clpt.2009.249","is_oa":false,"landing_page_url":"https://doi.org/10.1038/clpt.2009.249","pdf_url":null,"source":{"id":"https://openalex.org/S159852663","display_name":"Clinical Pharmacology & Therapeutics","issn_l":"0009-9236","issn":["0009-9236","1085-8733","1532-6535"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology &amp; Therapeutics","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"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/A5012370449","display_name":"Sean Hennessy","orcid":"https://orcid.org/0000-0003-4726-9413","observed_orcids":["https://orcid.org/0000-0003-4726-9413"]},"institutions":[{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"S Hennessy","raw_affiliation_strings":["University of Pennsylvania Center for Education and Research on Therapeutics and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA. hennessy@upenn.edu","University of Pennsylvania Center for Education and Research on Therapeutics and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Pennsylvania Center for Education and Research on Therapeutics and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA. hennessy@upenn.edu","institution_ids":["https://openalex.org/I79576946"]},{"raw_affiliation_string":"University of Pennsylvania Center for Education and Research on Therapeutics and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA","institution_ids":["https://openalex.org/I79576946"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5043526096","display_name":"Charles E. Leonard","orcid":"https://orcid.org/0000-0002-5092-9657","observed_orcids":["https://orcid.org/0000-0002-5092-9657"]},"institutions":[{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"C E Leonard","raw_affiliation_strings":["University of Pennsylvania Center for Education and Research on Therapeutics and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Pennsylvania Center for Education and Research on Therapeutics and Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA","institution_ids":["https://openalex.org/I79576946"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5014967450","display_name":"Richard G. Platt","orcid":"https://orcid.org/0000-0002-3248-3583","observed_orcids":["https://orcid.org/0000-0002-3248-3583"]},"institutions":[{"id":"https://openalex.org/I136199984","display_name":"Harvard University","ror":"https://ror.org/03vek6s52","country_code":"US","type":"education","lineage":["https://openalex.org/I136199984"]},{"id":"https://openalex.org/I4210111543","display_name":"Harvard Pilgrim Health Care","ror":"https://ror.org/01zxdeg39","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210111543"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"R Platt","raw_affiliation_strings":["HMO Research Network Center for Education and Research on Therapeutics and Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"HMO Research Network Center for Education and Research on Therapeutics and Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA","institution_ids":["https://openalex.org/I136199984","https://openalex.org/I4210111543"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5012370449"],"corresponding_institution_ids":["https://openalex.org/I79576946"],"apc_list":{"value":4410,"currency":"USD","value_usd":4410},"apc_paid":null,"fwci":1.5624,"has_fulltext":false,"cited_by_count":22,"citation_normalized_percentile":{"value":0.8115234,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":98},"biblio":{"volume":"87","issue":"2","first_page":"157","last_page":"159"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.9901999831199646,"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":0.9901999831199646,"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/T11792","display_name":"Pharmaceutical Economics and Policy","score":0.008200000040233135,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.00039999998989515007,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/biosimilars","display_name":"biosimilars","score":1.0},{"id":"https://openalex.org/keywords/administrative-claims-data","display_name":"administrative claims data","score":0.6600000262260437},{"id":"https://openalex.org/keywords/drug-safety","display_name":"drug safety","score":0.5590000152587891},{"id":"https://openalex.org/keywords/comparative-effectiveness","display_name":"comparative effectiveness","score":0.972000002861023},{"id":"https://openalex.org/keywords/fda-regulation","display_name":"FDA regulation","score":0.6340000033378601},{"id":"https://openalex.org/keywords/population-based-study","display_name":"population-based study","score":0.41200000047683716}],"concepts":[{"id":"https://openalex.org/C59491497","wikidata":"https://www.wikidata.org/wiki/Q864715","display_name":"Biosimilar","level":2,"score":0.990154504776001},{"id":"https://openalex.org/C2776473838","wikidata":"https://www.wikidata.org/wiki/Q174165","display_name":"Innovator","level":3,"score":0.8492496013641357},{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.7659621238708496},{"id":"https://openalex.org/C2777351106","wikidata":"https://www.wikidata.org/wiki/Q49371","display_name":"Legislation","level":2,"score":0.6045222878456116},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.49889397621154785},{"id":"https://openalex.org/C182306322","wikidata":"https://www.wikidata.org/wiki/Q1779371","display_name":"Order (exchange)","level":2,"score":0.4816383421421051},{"id":"https://openalex.org/C2908647359","wikidata":"https://www.wikidata.org/wiki/Q2625603","display_name":"Population","level":2,"score":0.41348084807395935},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.4132188558578491},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.41223737597465515},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.39222657680511475},{"id":"https://openalex.org/C100001284","wikidata":"https://www.wikidata.org/wiki/Q2248246","display_name":"Public economics","level":1,"score":0.35150885581970215},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.21393394470214844},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.18834322690963745},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.1859332025051117},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.18290206789970398},{"id":"https://openalex.org/C10138342","wikidata":"https://www.wikidata.org/wiki/Q43015","display_name":"Finance","level":1,"score":0.09747925400733948},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.0},{"id":"https://openalex.org/C84309077","wikidata":"https://www.wikidata.org/wiki/Q3908516","display_name":"Entrepreneurship","level":2,"score":0.0}],"mesh":[{"descriptor_ui":"D001688","descriptor_name":"Biological Products","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D001688","descriptor_name":"Biological Products","qualifier_ui":"Q000494","qualifier_name":"pharmacology","is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007880","descriptor_name":"Legislation, Drug","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D013810","descriptor_name":"Therapeutic Equivalency","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016568","descriptor_name":"Drugs, Generic","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D016568","descriptor_name":"Drugs, Generic","qualifier_ui":"Q000494","qualifier_name":"pharmacology","is_major_topic":true},{"descriptor_ui":"D017277","descriptor_name":"Drug Approval","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D057186","descriptor_name":"Comparative Effectiveness Research","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1038/clpt.2009.249","doi":"https://doi.org/10.1038/clpt.2009.249","is_oa":false,"landing_page_url":"https://doi.org/10.1038/clpt.2009.249","pdf_url":null,"source":{"id":"https://openalex.org/S159852663","display_name":"Clinical Pharmacology & Therapeutics","issn_l":"0009-9236","issn":["0009-9236","1085-8733","1532-6535"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Pharmacology &amp; Therapeutics","raw_type":"journal-article"},{"id":"pmid:20107450","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/20107450","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":"Clinical pharmacology and therapeutics","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320309370","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10"},{"id":"https://openalex.org/F4320332163","display_name":"U.S. Food and Drug Administration","ror":"https://ror.org/034xvzb47"}],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":3,"referenced_works":["https://openalex.org/W178874106","https://openalex.org/W1966687213","https://openalex.org/W1996927047"],"related_works":["https://openalex.org/W2592308167","https://openalex.org/W2501048415","https://openalex.org/W6923556459","https://openalex.org/W2086689296","https://openalex.org/W4280560199","https://openalex.org/W3012285886","https://openalex.org/W2161153559","https://openalex.org/W2108215882","https://openalex.org/W4402250502","https://openalex.org/W4399369393"],"abstract_inverted_index":{"As":[0],"Congress":[1],"begins":[2],"drafting":[3],"legislation":[4],"concerning":[5],"the":[6,36,55],"US":[7],"Food":[8],"and":[9,46,60],"Drug":[10],"Administration":[11],"(FDA)":[12],"regulation":[13],"of":[14,35,57],"biosimilars,":[15],"it":[16,33],"is":[17,34],"critical":[18],"to":[19,39,42,53,73],"keep":[20],"in":[21,48,51,76],"mind":[22],"that":[23,68],"these":[24,71],"agents":[25,72],"may":[26],"differ":[27],"from":[28],"their":[29],"innovator":[30],"compounds.":[31],"Therefore,":[32],"utmost":[37],"importance":[38],"be":[40,74],"able":[41],"differentiate":[43],"among":[44],"innovators":[45],"biosimilars":[47],"administrative":[49],"data":[50],"order":[52],"facilitate":[54],"conduct":[56],"population-based":[58],"safety":[59],"comparative":[61],"effectiveness":[62],"studies.":[63],"This":[64],"Commentary":[65],"proposes":[66],"methods":[67],"would":[69],"allow":[70],"distinguished":[75],"such":[77],"data.":[78]},"counts_by_year":[{"year":2022,"cited_by_count":1},{"year":2019,"cited_by_count":1},{"year":2018,"cited_by_count":1},{"year":2017,"cited_by_count":1},{"year":2016,"cited_by_count":3},{"year":2015,"cited_by_count":2},{"year":2014,"cited_by_count":1},{"year":2013,"cited_by_count":4},{"year":2012,"cited_by_count":1}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}
