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 |
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container_title | Cardiovascular Disorders in Hemodialysis |
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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 |
format | Article |
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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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