Biosimilars and the extrapolation of indications for inflammatory conditions

John RP Tesser,1 Daniel E Furst,2 Ira Jacobs3 1Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, 2UCLA Health, Los Angeles, CA, 3Pfizer Inc, New York, NY, USA Abstract: Extrapolation is the approval of a biosimilar for use in an indication held by the originator biologic not directly...

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Autores principales:	Tesser JRP, Furst DE, Jacobs I
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	biosimilar extrapolation inflammatory disease rheumatology Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/3ad9986b0aed40c098ffc77ac331ae22
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spelling	oai:doaj.org-article:3ad9986b0aed40c098ffc77ac331ae222021-12-02T00:36:08ZBiosimilars and the extrapolation of indications for inflammatory conditions1177-5491https://doaj.org/article/3ad9986b0aed40c098ffc77ac331ae222017-02-01T00:00:00Zhttps://www.dovepress.com/biosimilars-and-the-extrapolation-of-indications-for-inflammatory-cond-peer-reviewed-article-BTThttps://doaj.org/toc/1177-5491John RP Tesser,1 Daniel E Furst,2 Ira Jacobs3 1Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, 2UCLA Health, Los Angeles, CA, 3Pfizer Inc, New York, NY, USA Abstract: Extrapolation is the approval of a biosimilar for use in an indication held by the originator biologic not directly studied in a comparative clinical trial with the biosimilar. Extrapolation is a scientific rationale that bridges all the data collected (ie, totality of the evidence) from one indication for the biosimilar product to all the indications originally approved for the originator. Regulatory approval and marketing authorization of biosimilars in inflammatory indications are made on a case-by-case and agency-by-agency basis after evaluating the totality of evidence from the entire development program. This totality of the evidence comprises extensive comparative analytical, functional, nonclinical, and clinical pharmacokinetic/pharmacodynamic, efficacy, safety, and immunogenicity studies used by regulators when evaluating whether a product can be considered a biosimilar. Extrapolation reduces or eliminates the need for duplicative clinical studies of the biosimilar but must be justified scientifically with appropriate data. Understanding the concept, application, and regulatory decisions based on the extrapolation of data is important since biosimilars have the potential to significantly impact patient care in inflammatory diseases. Keywords: biosimilar, extrapolation, inflammatory disease, rheumatologyTesser JRPFurst DEJacobs IDove Medical Pressarticlebiosimilarextrapolationinflammatory diseaserheumatologyMedicine (General)R5-920ENBiologics: Targets & Therapy, Vol Volume 11, Pp 5-11 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	biosimilar extrapolation inflammatory disease rheumatology Medicine (General) R5-920
spellingShingle	biosimilar extrapolation inflammatory disease rheumatology Medicine (General) R5-920 Tesser JRP Furst DE Jacobs I Biosimilars and the extrapolation of indications for inflammatory conditions
description	John RP Tesser,1 Daniel E Furst,2 Ira Jacobs3 1Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, 2UCLA Health, Los Angeles, CA, 3Pfizer Inc, New York, NY, USA Abstract: Extrapolation is the approval of a biosimilar for use in an indication held by the originator biologic not directly studied in a comparative clinical trial with the biosimilar. Extrapolation is a scientific rationale that bridges all the data collected (ie, totality of the evidence) from one indication for the biosimilar product to all the indications originally approved for the originator. Regulatory approval and marketing authorization of biosimilars in inflammatory indications are made on a case-by-case and agency-by-agency basis after evaluating the totality of evidence from the entire development program. This totality of the evidence comprises extensive comparative analytical, functional, nonclinical, and clinical pharmacokinetic/pharmacodynamic, efficacy, safety, and immunogenicity studies used by regulators when evaluating whether a product can be considered a biosimilar. Extrapolation reduces or eliminates the need for duplicative clinical studies of the biosimilar but must be justified scientifically with appropriate data. Understanding the concept, application, and regulatory decisions based on the extrapolation of data is important since biosimilars have the potential to significantly impact patient care in inflammatory diseases. Keywords: biosimilar, extrapolation, inflammatory disease, rheumatology
format	article
author	Tesser JRP Furst DE Jacobs I
author_facet	Tesser JRP Furst DE Jacobs I
author_sort	Tesser JRP
title	Biosimilars and the extrapolation of indications for inflammatory conditions
title_short	Biosimilars and the extrapolation of indications for inflammatory conditions
title_full	Biosimilars and the extrapolation of indications for inflammatory conditions
title_fullStr	Biosimilars and the extrapolation of indications for inflammatory conditions
title_full_unstemmed	Biosimilars and the extrapolation of indications for inflammatory conditions
title_sort	biosimilars and the extrapolation of indications for inflammatory conditions
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/3ad9986b0aed40c098ffc77ac331ae22
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Biosimilars and the extrapolation of indications for inflammatory conditions

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