{"id":"https://openalex.org/W2946869899","doi":"https://doi.org/10.22037/ijpr.2019.14503.12441","title":"A Comparison Study of Efficacy and Safety of a Biosimilar Form of Intramuscular \u0392eta-interferon I-a Versus the Reference Product: A Randomized Controlled Clinical Trial in Iran.","display_name":"A Comparison Study of Efficacy and Safety of a Biosimilar Form of Intramuscular \u0392eta-interferon I-a Versus the Reference Product: A Randomized Controlled Clinical Trial in Iran.","publication_year":2019,"publication_date":"2019-01-01","ids":{"openalex":"https://openalex.org/W2946869899","doi":"https://doi.org/10.22037/ijpr.2019.14503.12441","mag":"2946869899","pmid":"https://pubmed.ncbi.nlm.nih.gov/32641970","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/6934945"},"language":"en","primary_location":{"id":"pmh:oai:pubmedcentral.nih.gov:6934945","doi":"https://doi.org/10.22037/ijpr.2019.14503.12441","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/6934945","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"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":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Iran J Pharm Res","raw_type":"Text"},"volume":null,"type":"article","indexed_in":["pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/6934945","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5046282061","display_name":"Seyed Massood Nabavi","orcid":"https://orcid.org/0000-0002-9814-8083","observed_orcids":["https://orcid.org/0000-0002-9814-8083"]},"institutions":[{"id":"https://openalex.org/I202419968","display_name":"Royan Institute","ror":"https://ror.org/02exhb815","country_code":"IR","type":"nonprofit","lineage":["https://openalex.org/I202419968"]}],"countries":["IR"],"is_corresponding":false,"raw_author_name":"Seyed Massood Nabavi","raw_affiliation_strings":["Department of Brain and Cognitive Sciences, Royan Institute for Stem Cell Biology and Technology, Tehran, Iran"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Brain and Cognitive Sciences, Royan Institute for Stem Cell Biology and Technology, Tehran, Iran","institution_ids":["https://openalex.org/I202419968"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5079526892","display_name":"Roya Abolfazli","orcid":"https://orcid.org/0000-0002-3506-7200","observed_orcids":["https://orcid.org/0000-0002-3506-7200"]},"institutions":[{"id":"https://openalex.org/I4404532917","display_name":"AmirAlam Hospital","ror":"https://ror.org/02ckdts26","country_code":"IR","type":"healthcare","lineage":["https://openalex.org/I4404532917"]},{"id":"https://openalex.org/I70640408","display_name":"Tehran University of Medical Sciences","ror":"https://ror.org/01c4pz451","country_code":"IR","type":"education","lineage":["https://openalex.org/I70640408"]}],"countries":["IR"],"is_corresponding":false,"raw_author_name":"Roya Abolfazli","raw_affiliation_strings":["Department of Neurology, Amir Alam Hospital, Tehran University of Medical Sciences, Tehran, Iran"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Neurology, Amir Alam Hospital, Tehran University of Medical Sciences, Tehran, Iran","institution_ids":["https://openalex.org/I4404532917","https://openalex.org/I70640408"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5070993407","display_name":"Ali Etemadrezaei","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Ali Etemadrezaei","raw_affiliation_strings":["Actoverco Pharmaceuticals, Tehran, Iran"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Actoverco Pharmaceuticals, Tehran, Iran","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5040183629","display_name":"Hamed Hosseini","orcid":"https://orcid.org/0000-0003-2368-6749","observed_orcids":["https://orcid.org/0000-0003-2368-6749"]},"institutions":[{"id":"https://openalex.org/I70640408","display_name":"Tehran University of Medical Sciences","ror":"https://ror.org/01c4pz451","country_code":"IR","type":"education","lineage":["https://openalex.org/I70640408"]}],"countries":["IR"],"is_corresponding":false,"raw_author_name":"Hamed Hosseini","raw_affiliation_strings":["Clinical Trial Center, Tehran University of Medical Sciences, Tehran, Iran"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Trial Center, Tehran University of Medical Sciences, Tehran, Iran","institution_ids":["https://openalex.org/I70640408"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5021243455","display_name":"Nahid Moradi","orcid":"https://orcid.org/0000-0001-6253-4487","observed_orcids":["https://orcid.org/0000-0001-6253-4487"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Nahid Moradi","raw_affiliation_strings":["Shefa Neuroscience Research Center, Tehran, Iran"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Shefa Neuroscience Research Center, Tehran, Iran","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5045589236","display_name":"Sanaz Shahriari","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Sanaz Shahriari","raw_affiliation_strings":["Actoverco Pharmaceuticals, Tehran, Iran"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Actoverco Pharmaceuticals, Tehran, Iran","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5049175402","display_name":"Baharak Mehdipour-Aghabagher","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Baharak Mehdipour","raw_affiliation_strings":["Actoverco Pharmaceuticals, Tehran, Iran"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Actoverco Pharmaceuticals, Tehran, Iran","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5062725171","display_name":"Babak Shekarchi","orcid":"https://orcid.org/0000-0001-9741-9825","observed_orcids":["https://orcid.org/0000-0001-9741-9825","https://orcid.org/0009-0004-2251-8385"]},"institutions":[{"id":"https://openalex.org/I2800605188","display_name":"Aja University of Medical Sciences","ror":"https://ror.org/028dyak29","country_code":"IR","type":"education","lineage":["https://openalex.org/I2800605188"]}],"countries":["IR"],"is_corresponding":false,"raw_author_name":"Babak Shekarchi","raw_affiliation_strings":["Department of Radiology, School of Medicine, Aja University of Medical Sciences, Tehran, Iran"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Radiology, School of Medicine, Aja University of Medical Sciences, Tehran, Iran","institution_ids":["https://openalex.org/I2800605188"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5069434722","display_name":"Akbar Soltanzadeh","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I70640408","display_name":"Tehran University of Medical Sciences","ror":"https://ror.org/01c4pz451","country_code":"IR","type":"education","lineage":["https://openalex.org/I70640408"]}],"countries":["IR"],"is_corresponding":false,"raw_author_name":"Akbar Soltanzadeh","raw_affiliation_strings":["Department of Neurology, Faculty of Medical, Tehran University of Medical Sciences, Tehran, Iran"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Neurology, Faculty of Medical, Tehran University of Medical Sciences, Tehran, Iran","institution_ids":["https://openalex.org/I70640408"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":4,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.184,"has_fulltext":false,"cited_by_count":2,"citation_normalized_percentile":{"value":0.51082162,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":94},"biblio":{"volume":"18","issue":"3","first_page":"1632","last_page":"1638"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10137","display_name":"Multiple Sclerosis Research Studies","score":0.8539999723434448,"subfield":{"id":"https://openalex.org/subfields/2734","display_name":"Pathology and Forensic Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10137","display_name":"Multiple Sclerosis Research Studies","score":0.8539999723434448,"subfield":{"id":"https://openalex.org/subfields/2734","display_name":"Pathology and Forensic Medicine"},"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/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.13930000364780426,"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/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.0003000000142492354,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/biosimilars","display_name":"biosimilars","score":0.9210000038146973},{"id":"https://openalex.org/keywords/relapsing-remitting-multiple-sclerosis","display_name":"relapsing-remitting multiple sclerosis","score":0.8899999856948853},{"id":"https://openalex.org/keywords/non-inferiority","display_name":"non-inferiority","score":0.9079999923706055},{"id":"https://openalex.org/keywords/efficacy","display_name":"efficacy","score":0.48399999737739563},{"id":"https://openalex.org/keywords/safety","display_name":"safety","score":0.8840000033378601},{"id":"https://openalex.org/keywords/expanded-disability-status-scale","display_name":"Expanded Disability Status Scale","score":0.8799999952316284},{"id":"https://openalex.org/keywords/relapse-rate","display_name":"relapse rate","score":0.9950000047683716},{"id":"https://openalex.org/keywords/mri-lesions","display_name":"MRI lesions","score":0.6290000081062317}],"concepts":[{"id":"https://openalex.org/C59491497","wikidata":"https://www.wikidata.org/wiki/Q864715","display_name":"Biosimilar","level":2,"score":0.9704864025115967},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8810396194458008},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.6363595128059387},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.5725407004356384},{"id":"https://openalex.org/C2780640218","wikidata":"https://www.wikidata.org/wiki/Q8277","display_name":"Multiple sclerosis","level":2,"score":0.530951201915741},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.4821019470691681},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.4759480953216553},{"id":"https://openalex.org/C2908698914","wikidata":"https://www.wikidata.org/wiki/Q2450337","display_name":"Interferon beta-1a","level":4,"score":0.44722476601600647},{"id":"https://openalex.org/C2994247566","wikidata":"https://www.wikidata.org/wiki/Q2450337","display_name":"Interferon beta","level":3,"score":0.21060216426849365},{"id":"https://openalex.org/C203014093","wikidata":"https://www.wikidata.org/wiki/Q101929","display_name":"Immunology","level":1,"score":0.1274891495704651}],"mesh":[],"locations_count":3,"locations":[{"id":"pmh:oai:pubmedcentral.nih.gov:6934945","doi":"https://doi.org/10.22037/ijpr.2019.14503.12441","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/6934945","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"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":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Iran J Pharm Res","raw_type":"Text"},{"id":"pmid:32641970","doi":"https://doi.org/10.22037/ijpr.2019.14503.12441","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/32641970","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":"Iranian journal of pharmaceutical research : IJPR","raw_type":"Journal Article"},{"id":"mag:2946869899","doi":"https://doi.org/10.22037/ijpr.2019.14503.12441","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/32641970","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":null,"is_accepted":false,"is_published":false,"raw_source_name":"PubMed","raw_type":null}],"best_oa_location":{"id":"pmh:oai:pubmedcentral.nih.gov:6934945","doi":"https://doi.org/10.22037/ijpr.2019.14503.12441","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/6934945","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"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":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Iran J Pharm Res","raw_type":"Text"},"sustainable_development_goals":[{"score":0.9940000176429749,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Randomized Controlled Trial","id":"https://openalex.org/study-designs/randomized-controlled-trial"},{"display_name":"Clinical Trial","id":"https://openalex.org/study-designs/clinical-trial"}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":10,"referenced_works":["https://openalex.org/W1529192025","https://openalex.org/W1535238031","https://openalex.org/W1987422544","https://openalex.org/W2034831904","https://openalex.org/W2102975036","https://openalex.org/W2131709112","https://openalex.org/W2133330282","https://openalex.org/W2138808841","https://openalex.org/W2145167133","https://openalex.org/W2413721625"],"related_works":["https://openalex.org/W2138808841","https://openalex.org/W2524728108","https://openalex.org/W2473159550","https://openalex.org/W2771555562","https://openalex.org/W2339008863","https://openalex.org/W2953114457","https://openalex.org/W2602907308","https://openalex.org/W2888906621","https://openalex.org/W2008009277","https://openalex.org/W2340633114"],"abstract_inverted_index":{"We":[0,60],"compared":[1],"the":[2,14,18,46,50,99,103,121,127,135,157,164,171,185,199],"efficacy":[3,177],"and":[4,49,67,82,86,94,102,150,152,195,206],"safety":[5],"of":[6,10,20,113,126,139,156,176],"a":[7,27,110],"biosimilar":[8,47,100,128,165,186],"form":[9],"beta-interferon-1a":[11],"(Actovex)":[12],"versus":[13],"reference":[15,51,104,172,200],"product":[16,173,201],"in":[17,63,115,124,147,174],"treatment":[19,52],"relapsing":[21],"remitting":[22],"multiple":[23],"sclerosis":[24],"(RRMS).":[25],"In":[26,73,183],"double":[28],"blind,":[29],"randomized":[30],"phase":[31],"3":[32],"clinical":[33],"trial,":[34],"we":[35],"evaluated":[36],"138":[37],"patients":[38,75],"with":[39],"RRMS":[40],"that":[41,163],"were":[42,77,142],"allocated":[43,78],"to":[44,79,170,198,203],"receive":[45],"medication":[48,101],"(30":[53],"\u03bcg":[54],"intramuscular,":[55],"weekly":[56],"for":[57,98],"one":[58,71],"year).":[59],"investigated":[61],"changes":[62,69],"EDSS,":[64],"relapse":[65,148],"rate":[66,149],"MRI":[68],"within":[70],"year.":[72],"sixty-nine":[74],"who":[76],"each":[80],"arm":[81,105],"analyzed":[83],"mean":[84,111],"age":[85],"its":[87],"standard":[88],"deviation":[89],"was":[90],"32.4":[91],"\u00b1":[92,96],"8.8":[93],"31.5":[95],"8":[97],"respectively.":[106],"One-year":[107],"follow-up":[108],"revealed":[109],"difference":[112],"0.084":[114],"EDSS":[116],"(95%":[117],"CI:":[118],"0.069-0.237)":[119],"between":[120],"two":[122,158],"groups":[123],"favor":[125],"medication.":[129],"This":[130],"value":[131],"did":[132],"not":[133],"exceed":[134],"predefined":[136],"non-inferiority":[137],"margin":[138],"0.1.":[140],"There":[141],"no":[143],"statistically":[144],"significant":[145],"differences":[146],"systemic":[151],"local":[153],"adverse":[154],"events":[155],"groups.":[159],"The":[160],"results":[161],"show":[162],"interferon":[166,187],"1-a":[167,188],"is":[168],"non-inferior":[169],"terms":[175],"while":[178],"it":[179],"demonstrates":[180],"comparable":[181],"safety.":[182],"conclusion":[184],"can":[189],"be":[190],"considered":[191],"as":[192],"an":[193],"effective":[194],"safe":[196],"alternative":[197],"due":[202],"lower":[204],"cost":[205],"more":[207],"availability.":[208]},"counts_by_year":[{"year":2024,"cited_by_count":1},{"year":2021,"cited_by_count":1}],"updated_date":"2026-10-28T10:33:24.094632","created_date":"2019-06-07T00:00:00"}