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Start Over Author "Giovanna Scroccaro" Journal contributions to nephrology
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1. Biosimilars, generic versions of the first generation of therapeutic proteins: do they exist?

Author

Daan, Crommelin, Theresa, Bermejo, Marco, Bissig, Jaak, Damiaans, Irene, Krämer, Patrick, Rambourg, Giovanna, Scroccaro, Borut, Strukelj, Roger, Tredree, and Claudio, Ronco

Subjects
Molecular Weight, Drug Stability, Molecular Structure, Pharmaceutical Preparations, Antibody Formation, Drugs, Generic, Humans, Recombinant Proteins, Biopharmaceutics
Abstract

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.

Published
2005

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