New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrap...

Autores
Feijó Azevedo, Valderilio; Babini, Alejandra; Vieira Teixeira, Fabio; Age Kos, Igor; Matar, Pablo
Año de publicación
2016
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders, including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other healthcare professionals, to present and discuss recent findings regarding biosimilars. In 2015, the meeting theme was interchangeability and automatic substitution. Regarding biosimilarity, interchangeability and extrapolation of indications, the discussion centred on two products in Brazil and Argentina: CT-P13, an infliximab biosimilar; and RTXM83, a rituximab biosimilar. Here, we conduct a critical analysis of the available scientific and medical information on these products to establish a FLAB position statement in the context of the current regulations in Brazil and Argentina. Biosimilarity, interchangeability and extrapolation of indications: RTXM83 is still not approved in Brazil and is currently under a technology transfer agreement. In Argentina, the drug was approved for commercialization under the name Novex, with extrapolation of indications for rheumatoid arthritis, which according to the Argentinian Society of Rheumatology, lacks the necessary clinical data for such an approval. CT-P13 is already approved in Brazil, and is on the market. The approval was based on the data presented in the PLANETAS and PLANETRA studies. Interchangeability will not be considered for this product until further studies are presented. Discussion: Based on the available evidence, CT-P13 is the only biological molecule marketed in Latin America that can be considered a true biosimilar. Extrapolation is only acceptable when the diseases for which the reference product is intended to treat are entirely similar. Extrapolation based on only preclinical studies is not acceptable. Conversely, although the proposed rituximab biosimilar (RTXM83) was approved by ANMAT (National Administration for Medicines, Food and Medical Technology) in Argentina, clinical data demonstrating its equivalence with the reference rituximab, is necessary before RTXM83 can be considered a true biosimilar.
Fil: Feijó Azevedo, Valderilio. Universidade Federal do Paraná; Brasil. Health Research and Educational Center; Brasil
Fil: Babini, Alejandra. Hospital Italiano Córdoba; Argentina. Sociedad Argentina de Reumatología; Argentina
Fil: Vieira Teixeira, Fabio. Clínica Gastrosaude de Marilia; Brasil. Grupo de Estudos de Doença Inflamatória Intestinal; Brasil
Fil: Age Kos, Igor. Universidade Federal do Paraná; Brasil. Health Research and Educational Center; Brasil
Fil: Matar, Pablo. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario; Argentina
Materia
Biosimilarity
Extrapolation
Infliximab
Interchangeability
Monoclonal Antibodies
Rituximab
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/79369
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/79369
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indicationsFeijó Azevedo, ValderilioBabini, AlejandraVieira Teixeira, FabioAge Kos, IgorMatar, PabloBiosimilarityExtrapolationInfliximabInterchangeabilityMonoclonal AntibodiesRituximabhttps://purl.org/becyt/ford/3.4https://purl.org/becyt/ford/3Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders, including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other healthcare professionals, to present and discuss recent findings regarding biosimilars. In 2015, the meeting theme was interchangeability and automatic substitution. Regarding biosimilarity, interchangeability and extrapolation of indications, the discussion centred on two products in Brazil and Argentina: CT-P13, an infliximab biosimilar; and RTXM83, a rituximab biosimilar. Here, we conduct a critical analysis of the available scientific and medical information on these products to establish a FLAB position statement in the context of the current regulations in Brazil and Argentina. Biosimilarity, interchangeability and extrapolation of indications: RTXM83 is still not approved in Brazil and is currently under a technology transfer agreement. In Argentina, the drug was approved for commercialization under the name Novex, with extrapolation of indications for rheumatoid arthritis, which according to the Argentinian Society of Rheumatology, lacks the necessary clinical data for such an approval. CT-P13 is already approved in Brazil, and is on the market. The approval was based on the data presented in the PLANETAS and PLANETRA studies. Interchangeability will not be considered for this product until further studies are presented. Discussion: Based on the available evidence, CT-P13 is the only biological molecule marketed in Latin America that can be considered a true biosimilar. Extrapolation is only acceptable when the diseases for which the reference product is intended to treat are entirely similar. Extrapolation based on only preclinical studies is not acceptable. Conversely, although the proposed rituximab biosimilar (RTXM83) was approved by ANMAT (National Administration for Medicines, Food and Medical Technology) in Argentina, clinical data demonstrating its equivalence with the reference rituximab, is necessary before RTXM83 can be considered a true biosimilar.Fil: Feijó Azevedo, Valderilio. Universidade Federal do Paraná; Brasil. Health Research and Educational Center; BrasilFil: Babini, Alejandra. Hospital Italiano Córdoba; Argentina. Sociedad Argentina de Reumatología; ArgentinaFil: Vieira Teixeira, Fabio. Clínica Gastrosaude de Marilia; Brasil. Grupo de Estudos de Doença Inflamatória Intestinal; BrasilFil: Age Kos, Igor. Universidade Federal do Paraná; Brasil. Health Research and Educational Center; BrasilFil: Matar, Pablo. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario; ArgentinaPro Pharma Communications International2016-06info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/79369Feijó Azevedo, Valderilio; Babini, Alejandra; Vieira Teixeira, Fabio; Age Kos, Igor; Matar, Pablo; New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications; Pro Pharma Communications International; Generics and Biosimilars Initiative Journal; 5; 2; 6-2016; 66-692033-64032033-6772CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.5639/gabij.2016.0502.017info:eu-repo/semantics/altIdentifier/url/http://gabi-journal.net/new-monoclonal-antibody-biosimilars-approved-in-2015-in-latin-america-position-statement-of-the-latin-american-forum-on-biosimilars-on-biosimilarity-interchangeability-and-extrapolation-of-indications.htmlinfo:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T09:59:23Zoai:ri.conicet.gov.ar:11336/79369instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 09:59:23.473CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications
title New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications
spellingShingle New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications
Feijó Azevedo, Valderilio
Biosimilarity
Extrapolation
Infliximab
Interchangeability
Monoclonal Antibodies
Rituximab
title_short New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications
title_full New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications
title_fullStr New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications
title_full_unstemmed New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications
title_sort New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications
dc.creator.none.fl_str_mv Feijó Azevedo, Valderilio
Babini, Alejandra
Vieira Teixeira, Fabio
Age Kos, Igor
Matar, Pablo
author Feijó Azevedo, Valderilio
author_facet Feijó Azevedo, Valderilio
Babini, Alejandra
Vieira Teixeira, Fabio
Age Kos, Igor
Matar, Pablo
author_role author
author2 Babini, Alejandra
Vieira Teixeira, Fabio
Age Kos, Igor
Matar, Pablo
author2_role author
author
author
author
dc.subject.none.fl_str_mv Biosimilarity
Extrapolation
Infliximab
Interchangeability
Monoclonal Antibodies
Rituximab
topic Biosimilarity
Extrapolation
Infliximab
Interchangeability
Monoclonal Antibodies
Rituximab
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.4
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders, including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other healthcare professionals, to present and discuss recent findings regarding biosimilars. In 2015, the meeting theme was interchangeability and automatic substitution. Regarding biosimilarity, interchangeability and extrapolation of indications, the discussion centred on two products in Brazil and Argentina: CT-P13, an infliximab biosimilar; and RTXM83, a rituximab biosimilar. Here, we conduct a critical analysis of the available scientific and medical information on these products to establish a FLAB position statement in the context of the current regulations in Brazil and Argentina. Biosimilarity, interchangeability and extrapolation of indications: RTXM83 is still not approved in Brazil and is currently under a technology transfer agreement. In Argentina, the drug was approved for commercialization under the name Novex, with extrapolation of indications for rheumatoid arthritis, which according to the Argentinian Society of Rheumatology, lacks the necessary clinical data for such an approval. CT-P13 is already approved in Brazil, and is on the market. The approval was based on the data presented in the PLANETAS and PLANETRA studies. Interchangeability will not be considered for this product until further studies are presented. Discussion: Based on the available evidence, CT-P13 is the only biological molecule marketed in Latin America that can be considered a true biosimilar. Extrapolation is only acceptable when the diseases for which the reference product is intended to treat are entirely similar. Extrapolation based on only preclinical studies is not acceptable. Conversely, although the proposed rituximab biosimilar (RTXM83) was approved by ANMAT (National Administration for Medicines, Food and Medical Technology) in Argentina, clinical data demonstrating its equivalence with the reference rituximab, is necessary before RTXM83 can be considered a true biosimilar.
Fil: Feijó Azevedo, Valderilio. Universidade Federal do Paraná; Brasil. Health Research and Educational Center; Brasil
Fil: Babini, Alejandra. Hospital Italiano Córdoba; Argentina. Sociedad Argentina de Reumatología; Argentina
Fil: Vieira Teixeira, Fabio. Clínica Gastrosaude de Marilia; Brasil. Grupo de Estudos de Doença Inflamatória Intestinal; Brasil
Fil: Age Kos, Igor. Universidade Federal do Paraná; Brasil. Health Research and Educational Center; Brasil
Fil: Matar, Pablo. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario; Argentina
description Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders, including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other healthcare professionals, to present and discuss recent findings regarding biosimilars. In 2015, the meeting theme was interchangeability and automatic substitution. Regarding biosimilarity, interchangeability and extrapolation of indications, the discussion centred on two products in Brazil and Argentina: CT-P13, an infliximab biosimilar; and RTXM83, a rituximab biosimilar. Here, we conduct a critical analysis of the available scientific and medical information on these products to establish a FLAB position statement in the context of the current regulations in Brazil and Argentina. Biosimilarity, interchangeability and extrapolation of indications: RTXM83 is still not approved in Brazil and is currently under a technology transfer agreement. In Argentina, the drug was approved for commercialization under the name Novex, with extrapolation of indications for rheumatoid arthritis, which according to the Argentinian Society of Rheumatology, lacks the necessary clinical data for such an approval. CT-P13 is already approved in Brazil, and is on the market. The approval was based on the data presented in the PLANETAS and PLANETRA studies. Interchangeability will not be considered for this product until further studies are presented. Discussion: Based on the available evidence, CT-P13 is the only biological molecule marketed in Latin America that can be considered a true biosimilar. Extrapolation is only acceptable when the diseases for which the reference product is intended to treat are entirely similar. Extrapolation based on only preclinical studies is not acceptable. Conversely, although the proposed rituximab biosimilar (RTXM83) was approved by ANMAT (National Administration for Medicines, Food and Medical Technology) in Argentina, clinical data demonstrating its equivalence with the reference rituximab, is necessary before RTXM83 can be considered a true biosimilar.
publishDate 2016
dc.date.none.fl_str_mv 2016-06
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/79369
Feijó Azevedo, Valderilio; Babini, Alejandra; Vieira Teixeira, Fabio; Age Kos, Igor; Matar, Pablo; New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications; Pro Pharma Communications International; Generics and Biosimilars Initiative Journal; 5; 2; 6-2016; 66-69
2033-6403
2033-6772
CONICET Digital
CONICET
url http://hdl.handle.net/11336/79369
identifier_str_mv Feijó Azevedo, Valderilio; Babini, Alejandra; Vieira Teixeira, Fabio; Age Kos, Igor; Matar, Pablo; New monoclonal antibody biosimilars approved in 2015 in Latin America: Position statement of the Latin American Forum on Biosimilars in biosimilarity, interchangeability and extrapolation of indications; Pro Pharma Communications International; Generics and Biosimilars Initiative Journal; 5; 2; 6-2016; 66-69
2033-6403
2033-6772
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.5639/gabij.2016.0502.017
info:eu-repo/semantics/altIdentifier/url/http://gabi-journal.net/new-monoclonal-antibody-biosimilars-approved-in-2015-in-latin-america-position-statement-of-the-latin-american-forum-on-biosimilars-on-biosimilarity-interchangeability-and-extrapolation-of-indications.html
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Pro Pharma Communications International
publisher.none.fl_str_mv Pro Pharma Communications International
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.070432

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