Biosimilars, Generic Versions of the First Generation of Therapeutic Proteins: Do They Exist?

This contribution describes the present regulatory status in the EU of biosimilars, the generic versions of the first generation of therapeutic proteins. It points out why and where recombinant protein molecules and low-molecular-weight drugs differ in their behaviour and why biosimilars should be h...

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Veröffentlicht in:Cardiovascular Disorders in Hemodialysis 2005-01, Vol.149, p.287-294
Hauptverfasser: Crommelin, Daan, Bermejo, Theresa, Bissig, Marco, Damiaans, Jaak, Krämer, Irene, Rambourg, Patrick, Scroccaro, Giovanna, Strukelj, Borut, Tredree, Roger, Ronco, Claudio
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container_end_page 294
container_issue
container_start_page 287
container_title Cardiovascular Disorders in Hemodialysis
container_volume 149
creator Crommelin, Daan
Bermejo, Theresa
Bissig, Marco
Damiaans, Jaak
Krämer, Irene
Rambourg, Patrick
Scroccaro, Giovanna
Strukelj, Borut
Tredree, Roger
Ronco, Claudio
description This contribution describes the present regulatory status in the EU of biosimilars, the generic versions of the first generation of therapeutic proteins. It points out why and where recombinant protein molecules and low-molecular-weight drugs differ in their behaviour and why biosimilars should be handled differently than generic low-molecular-weight drugs. This information is important for practitioners (pharmacists and physicians) while selecting the best supplier of a therapeutic protein.
doi_str_mv 10.1159/000085690
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source Karger eBooks Collection Archiv (DFG Nationallizenzen); MEDLINE; Karger Book Series
subjects Antibody Formation
Biopharmaceutics - legislation & jurisprudence
Cardiovascular medicine
Chapter
Drug Stability
Drugs, Generic - chemistry
Haemodialysis
Humans
Molecular Structure
Molecular Weight
Pharmaceutical Preparations
Recombinant Proteins - chemistry
Renal medicine
title Biosimilars, Generic Versions of the First Generation of Therapeutic Proteins: Do They Exist?
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