Cargando…

Antibody biosimilars: Fears or opportunities?: First LabEx MAbImprove industrial workshop, May 28, 2013; Tours, France

The annual “LabEx MAbImprove industrial workshops” are primarily intended to provide scientists involved in therapeutic antibodies, a comprehensive view about topics of interest for the pharmaceutical industry. They are organized by the “LabEx MAbImprove industrial committee”, for this first edition...

Descripción completa

Detalles Bibliográficos
Autores principales: Guillon-Munos, Audrey, Daguet, Arnaud, Watier, Hervé
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Landes Bioscience 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4171015/
https://www.ncbi.nlm.nih.gov/pubmed/24714167
http://dx.doi.org/10.4161/mabs.28831
_version_ 1782335871949733888
author Guillon-Munos, Audrey
Daguet, Arnaud
Watier, Hervé
author_facet Guillon-Munos, Audrey
Daguet, Arnaud
Watier, Hervé
author_sort Guillon-Munos, Audrey
collection PubMed
description The annual “LabEx MAbImprove industrial workshops” are primarily intended to provide scientists involved in therapeutic antibodies, a comprehensive view about topics of interest for the pharmaceutical industry. They are organized by the “LabEx MAbImprove industrial committee”, for this first edition especially in partnership with ARITT, the regional agency for innovation and technology transfer which operates in the French Région Centre, the 1st French region for pharmaceutical production. The 2013 edition, held May 28 at the Vinci Center of Tours, was dedicated to antibody biosimilars. Depending on opinions, the impending expiry of antibody patents and the imminent marketing approval of competitors to blockbusters can be perceived as good or bad things. Fears or opportunities? Risks for patients? Breath of fresh air for the health systems? Opportunity for re-industrializing France? In this context, it is necessary for people to form a fair and informed opinion on the current landscape of antibody biosimilars. In particular, this is especially important for scientists from the academic world, from the industry or from the regulation agencies, for pharmacists, for pharmacovigilance specialists, for health authorities, and staff from health insurance and decision makers. The first session was devoted to market and regulatory issues, and included both an overview of the evolution of the patent landscape and a description of biosimilars regulation in the European Union (EU). This session was closed by a talk on manufacturing processes for biosimilars. In the next session, quality control attributes of biosimilars were discussed and compared with the consistent quality of biotechnology products to raise the question: “How close is close enough?” In vitro assays for evaluating the Fc function of therapeutic antibodies were also discussed. The third session focused on development of biosimilars and primarily on the stepwise process for introducing an antibody biosimilar on the EU market, and included a presentation of the ongoing clinical evaluation of an infliximab biosimilar. The session concluded with a rich debate on the indication extrapolation of a biosimilar compared to the originator. The last session was dedicated to societal issues and focused on two aspects: (1) the need of biosimilars for EU health economy; and (2) last but not least, the ethical issues about clinical evaluation of biosimilars. All speakers and attendees enjoyed this very stimulating and rewarding meeting, which gathered many people with divergent scientific backgrounds from the academic or industrial world.
format Online
Article
Text
id pubmed-4171015
institution National Center for Biotechnology Information
language English
publishDate 2014
publisher Landes Bioscience
record_format MEDLINE/PubMed
spelling pubmed-41710152015-07-01 Antibody biosimilars: Fears or opportunities?: First LabEx MAbImprove industrial workshop, May 28, 2013; Tours, France Guillon-Munos, Audrey Daguet, Arnaud Watier, Hervé MAbs Meeting Report The annual “LabEx MAbImprove industrial workshops” are primarily intended to provide scientists involved in therapeutic antibodies, a comprehensive view about topics of interest for the pharmaceutical industry. They are organized by the “LabEx MAbImprove industrial committee”, for this first edition especially in partnership with ARITT, the regional agency for innovation and technology transfer which operates in the French Région Centre, the 1st French region for pharmaceutical production. The 2013 edition, held May 28 at the Vinci Center of Tours, was dedicated to antibody biosimilars. Depending on opinions, the impending expiry of antibody patents and the imminent marketing approval of competitors to blockbusters can be perceived as good or bad things. Fears or opportunities? Risks for patients? Breath of fresh air for the health systems? Opportunity for re-industrializing France? In this context, it is necessary for people to form a fair and informed opinion on the current landscape of antibody biosimilars. In particular, this is especially important for scientists from the academic world, from the industry or from the regulation agencies, for pharmacists, for pharmacovigilance specialists, for health authorities, and staff from health insurance and decision makers. The first session was devoted to market and regulatory issues, and included both an overview of the evolution of the patent landscape and a description of biosimilars regulation in the European Union (EU). This session was closed by a talk on manufacturing processes for biosimilars. In the next session, quality control attributes of biosimilars were discussed and compared with the consistent quality of biotechnology products to raise the question: “How close is close enough?” In vitro assays for evaluating the Fc function of therapeutic antibodies were also discussed. The third session focused on development of biosimilars and primarily on the stepwise process for introducing an antibody biosimilar on the EU market, and included a presentation of the ongoing clinical evaluation of an infliximab biosimilar. The session concluded with a rich debate on the indication extrapolation of a biosimilar compared to the originator. The last session was dedicated to societal issues and focused on two aspects: (1) the need of biosimilars for EU health economy; and (2) last but not least, the ethical issues about clinical evaluation of biosimilars. All speakers and attendees enjoyed this very stimulating and rewarding meeting, which gathered many people with divergent scientific backgrounds from the academic or industrial world. Landes Bioscience 2014-07-01 2014-04-08 /pmc/articles/PMC4171015/ /pubmed/24714167 http://dx.doi.org/10.4161/mabs.28831 Text en Copyright © 2014 Landes Bioscience http://creativecommons.org/licenses/by-nc/3.0/ This is an open-access article licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. The article may be redistributed, reproduced, and reused for non-commercial purposes, provided the original source is properly cited.
spellingShingle Meeting Report
Guillon-Munos, Audrey
Daguet, Arnaud
Watier, Hervé
Antibody biosimilars: Fears or opportunities?: First LabEx MAbImprove industrial workshop, May 28, 2013; Tours, France
title Antibody biosimilars: Fears or opportunities?: First LabEx MAbImprove industrial workshop, May 28, 2013; Tours, France
title_full Antibody biosimilars: Fears or opportunities?: First LabEx MAbImprove industrial workshop, May 28, 2013; Tours, France
title_fullStr Antibody biosimilars: Fears or opportunities?: First LabEx MAbImprove industrial workshop, May 28, 2013; Tours, France
title_full_unstemmed Antibody biosimilars: Fears or opportunities?: First LabEx MAbImprove industrial workshop, May 28, 2013; Tours, France
title_short Antibody biosimilars: Fears or opportunities?: First LabEx MAbImprove industrial workshop, May 28, 2013; Tours, France
title_sort antibody biosimilars: fears or opportunities?: first labex mabimprove industrial workshop, may 28, 2013; tours, france
topic Meeting Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4171015/
https://www.ncbi.nlm.nih.gov/pubmed/24714167
http://dx.doi.org/10.4161/mabs.28831
work_keys_str_mv AT guillonmunosaudrey antibodybiosimilarsfearsoropportunitiesfirstlabexmabimproveindustrialworkshopmay282013toursfrance
AT daguetarnaud antibodybiosimilarsfearsoropportunitiesfirstlabexmabimproveindustrialworkshopmay282013toursfrance
AT watierherve antibodybiosimilarsfearsoropportunitiesfirstlabexmabimproveindustrialworkshopmay282013toursfrance