Carcinogenicity of biopharmaceuticals

Maggie Dempster; Kris Siezen; Baster Braak; Willem van den Brink; Annette Emerenciana; Francesco Bellanti; Ruben G. Duijnhoven; Marcel Kwa; Jan Willem van der Laan

doi:10.1007/978-3-319-22084-0_8

Carcinogenicity of biopharmaceuticals

Maggie Dempster^*
, Kris Siezen
, Baster Braak
, Willem van den Brink
, Annette Emerenciana
, Francesco Bellanti
, Ruben G. Duijnhoven
, Marcel Kwa
, Jan Willem van der Laan

^*Corresponding author for this work

GlaxoSmithKline
Medicines Evaluation Board
Leiden University
National Institute of Public Health and the Environment
Leiden Academic Center for Drug Research

Research output: Chapter in Book/Report/Conference proceeding › Chapter › Academic › peer-review

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Abstract

The physicochemical and biological properties of biopharmaceuticals are, in many aspects, different from small molecule drugs. These differences must also be taken into account when evaluating the risk of carcinogenicity in humans. For example, because of their expected biological activity, growth factors or immunomodulators present an inherent risk for potentially enhancing tumor incidence in humans.

Original language	English
Title of host publication	Genotoxicity and Carcinogenicity Testing of Pharmaceuticals
Publisher	Springer International Publishing Switzerland
Pages	125-157
Number of pages	33
ISBN (Electronic)	9783319220840
ISBN (Print)	9783319220833
DOIs	https://doi.org/10.1007/978-3-319-22084-0_8
Publication status	Published - 1 Jan 2015

Keywords

Biotechnology-derived pharmaceuticals
Carcinogenicity evaluation
GLP-1 agonists
Immunomodulators
Insulin
Non-clinical evaluation

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10.1007/978-3-319-22084-0_8

Carcinogenicity-of-biopharmaceuticals.pdfFinal published version, 3.04 MBLicence: Taverne

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AU - Dempster, Maggie

AU - Siezen, Kris

AU - Braak, Baster

AU - van den Brink, Willem

AU - Emerenciana, Annette

AU - Bellanti, Francesco

AU - Duijnhoven, Ruben G.

AU - Kwa, Marcel

AU - van der Laan, Jan Willem

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AB - The physicochemical and biological properties of biopharmaceuticals are, in many aspects, different from small molecule drugs. These differences must also be taken into account when evaluating the risk of carcinogenicity in humans. For example, because of their expected biological activity, growth factors or immunomodulators present an inherent risk for potentially enhancing tumor incidence in humans.

KW - Biotechnology-derived pharmaceuticals

KW - Carcinogenicity evaluation

KW - GLP-1 agonists

KW - Immunomodulators

KW - Insulin

KW - Non-clinical evaluation

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BT - Genotoxicity and Carcinogenicity Testing of Pharmaceuticals

PB - Springer International Publishing Switzerland

ER -

Carcinogenicity of biopharmaceuticals

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Keywords

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