By K. Ho, J.-H. Trouvin (auth.), Jean-Louis Prugnaud, Jean-Hugues Trouvin (eds.)
Biologics have revolutionised the therapy of many critical stipulations, supplying unheard of medical effects but additionally generating awfully excessive costs. As patents expire, copies and cost festival are anticipated through the global. despite the fact that, because of the intrinsic heterogeneity and molecular complexity of biologic medicinal items, their copies can't easily be licensed below the “generic rule” legitimate for small chemical entities.
In reaction, a devoted law was once issued within the ecu Union. it really is in accordance with the idea that of “biological medicinal items just like a organic reference product”, or “biosimilars”. This ebook analyses the context of biotechnological creation and addresses the ecu felony framework for biosimilar marketplace approval. It highlights post-market authorisation matters, corresponding to probability administration Plans and substitution of goods, and descriptions another matters, equivalent to expense administration and foreign nomenclature.
This e-book is basically meant for hospital-based physicians and pharmacists. it's going to even be a helpful source for all actors from all international locations who are looking to larger comprehend the emergence of those new medicinal items in the eu context.
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Additional info for Biosimilars: A New Generation of Biologics
However, this system remains limited to simple glycoproteins since yeasts produce N-glycosylations rich in mannose residues; strongly immunogenic for humans; • higher eukaryotes with mammalian cells, but also insect or plant cells. In general these cells are used in industrial production only when microbial or fungal are deemed not adapted to produce the protein of interest. In fact, unlike the systems above, higher eukaryotes are systems more difficult to industrially implement and with a lower yield (as compare to bacteria or yeast), and very constraining culture conditions.
Any difference between biosimilar and reference must be justified by appropriate study, case by case. A consultation with regulatory authorities is recommended for discussing these approaches. Quality Control Approach Biosimilars are biological products developed according to their own manufacturing process. Scientific data coming from pharmacopeia’ monographs or published in the literature on the reference biological medicinal product are considered as limited in order to establish the similarity between biosimilar and 26 M.
In single dose studies, the most relevant parameter is the number of reticulocytes, for it is a pharmacodynamic marker of erythropoietin’s activity. However this marker does not substitute for efficacy, since it is not directly correlated with hemoglobin level; • clinical biosimilarity must be demonstrated by comparative clinical studies powerful enough, randomised and in parallel groups between biosimilar and 34 M. -L. Prugnaud reference. As pharmacokinetics and efficient doses differ between IV and SC routes, studies must be conducted on each mode of injection.