Biosimilars: A New Generation of Biologics by K. Ho, J.-H. Trouvin (auth.), Jean-Louis Prugnaud,

By K. Ho, J.-H. Trouvin (auth.), Jean-Louis Prugnaud, Jean-Hugues Trouvin (eds.)

Biologics have revolutionised the remedy of many serious stipulations, providing remarkable scientific effects but additionally generating awfully excessive costs. As patents expire, copies and cost pageant are anticipated during the global. even though, as a result of intrinsic heterogeneity and molecular complexity of biologic medicinal items, their copies can't easily be licensed lower than the “generic rule” legitimate for small chemical entities.

In reaction, a devoted rules used to be issued within the eu Union. it really is in keeping with the idea that of “biological medicinal items just like a organic reference product”, or “biosimilars”. This publication analyses the context of biotechnological construction and addresses the eu felony framework for biosimilar industry approval. It highlights post-market authorisation concerns, equivalent to possibility administration Plans and substitution of goods, and descriptions another concerns, resembling price administration and foreign nomenclature.

This e-book is essentially meant for hospital-based physicians and pharmacists. it is going to even be a invaluable source for all actors from all nations who are looking to higher comprehend the emergence of those new medicinal items in the eu context.

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Guidance on Similar Medicinal Products containing Recombinant Human Insulin (CHMP adopted February 2006) • EMEA/CHMP/42832/05 Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues • EMEA/CHMP/42832/05 Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues (CHMP adopted February 2006) • EMEA/CHMP/437/04 Guideline on Similar Biological Medicinal Products • EMEA/CHMP/437/04 Guideline on Similar Biological Medicinal Products (CHMP adopted September 2005) • EMEA/CHMP/94526/05 Annex Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues.

Only one soluble isoform that attaches itself to the extracellular part of the receptor is known. The extracellular binding domains of known isoforms are identical. Consequently, G-CSF effects are mediated by only one class of receptors. The approval application and marketing of a G-CSF biosimilar require comparative studies of non-clinical and clinical quality. Non Clinical Program for rG-CSF The non-clinical program includes: • comparative pharmacodynamic studies: – in vitro at receptor level on adapted cellular models, to measure biological activity; – in vivo on neutropenic and non neutropenic rodent models, in order to compare the biosimilar effects to those of the reference; • toxicology studies with a single or repeat dose to a relevant species for at least 28 days.

Doses Vary with Indications G-CSF acts on target-cells through a membrane receptor. Only one soluble isoform that attaches itself to the extracellular part of the receptor is known. The extracellular binding domains of known isoforms are identical. Consequently, G-CSF effects are mediated by only one class of receptors. The approval application and marketing of a G-CSF biosimilar require comparative studies of non-clinical and clinical quality. Non Clinical Program for rG-CSF The non-clinical program includes: • comparative pharmacodynamic studies: – in vitro at receptor level on adapted cellular models, to measure biological activity; – in vivo on neutropenic and non neutropenic rodent models, in order to compare the biosimilar effects to those of the reference; • toxicology studies with a single or repeat dose to a relevant species for at least 28 days.

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