Abstract
The « standard » generic approach, that requires for a chemical substance a simple demonstration of bio-equivalence with the reference product is not adequate to evidence a biosimilar’s quality, safety and efficacy, due to the complexity of the products themselves but also of their production processes. The registration of biological products’ copies has been made possible by the creation of a specific regulatory framework by European regulatory authorities, This framework is referred to as « biosimilar approach ». In this chapter are described the general framework of registration and applications specific to onco-hematology field, through the examples of rG-CSF and EPO
Pavlovic article
M, Girardin E, Kapetanovic L, Ho H et Trouvin JH, Similar Biological Medicinal Products Containing Recombinant Human Growth Hormone: European Regulation. Horm Res 2008;69:14–21. © 2007. Karger AG, Basel.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Notes
- 1.
Guideline on Similar Biological Medicinal Products. CHMP/437/04 (CHMP adopted September 2005).
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer-Verlag France
About this chapter
Cite this chapter
Pavlovic, M., Prugnaud, JL. (2013). From the Biosimilar Concept to the Marketing Authorisation. In: Prugnaud, JL., Trouvin, JH. (eds) Biosimilars. Springer, Paris. https://doi.org/10.1007/978-2-8178-0336-4_2
Download citation
DOI: https://doi.org/10.1007/978-2-8178-0336-4_2
Published:
Publisher Name: Springer, Paris
Print ISBN: 978-2-8178-0335-7
Online ISBN: 978-2-8178-0336-4
eBook Packages: MedicineMedicine (R0)