By K. Ho, J.-H. Trouvin (auth.), Jean-Louis Prugnaud, Jean-Hugues Trouvin (eds.)
Biologics have revolutionised the therapy of many critical stipulations, providing remarkable medical effects but in addition generating really excessive costs. As patents expire, copies and value festival are anticipated in the course of the international. despite the fact that, 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 committed legislation was once issued within the eu Union. it truly is in accordance 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 criminal framework for biosimilar industry approval. It highlights post-market authorisation matters, corresponding to threat administration Plans and substitution of goods, and descriptions another concerns, resembling price administration and foreign nomenclature.
This e-book is basically meant for hospital-based physicians and pharmacists. it is going to even be a invaluable source for all actors from all international locations who are looking to higher comprehend the emergence of those new medicinal items in the ecu context.
Read or Download Biosimilars: A New Generation of Biologics PDF
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Extra info for Biosimilars: A New Generation of Biologics
Clinical development requires data concerning a proof of concept, dose evaluation and demonstration of efficacy in pivotal studies conducted in the medicine’s target population. Based on quality, preclinical and clinical studies, stored during its development, the medicine may be ready to be filed in order to get a Marketing Authorisation (MA). As for chemical medicines, the application biosimilar approach necessitates the development of the manufacturing process (for the active substance and finished product), and the demonstration of safety and efficacy through non-clinical and clinical studies.
In the same general recommendations, the same biological reference must be used for the whole program of comparability of quality safety and efficacy studies, in order to ensure that responses during the comparability exercise be obtained with a single comparator, having all along the studies concerning the same form and same dosage, the same types of impurities and variants linked to its manufacturing process. A biosimilar’s active substance must be similar in molecular and biological terms to the reference product.
Clinical Program for rG-CSF The clinical program to compare biosimilar to the reference product includes: • pharmacokinetics studies in crossed single dose for the different routes of administration (subcutaneous, and intravenous) in healthy volunteers. Studied parameters include the area under the curve (AUC), the C max and T with an evaluation performed according to bioequivalence general principles; • pharmacodynamics studies—the absolute number of neutrophils is the pharmacodynamics marker the most relevant for G-CSF activity.