Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2478233 | Annales Pharmaceutiques Françaises | 2008 | 6 Pages |
Abstract
Directive 2004/27/EC, issued by the European commission specifies the conditions by which marketing approval can be awarded for a biosimilar drug, whose structure is the closest possible to that of an already marketed biotechnology-drug. This specific regulation differs in more than one point from that applied to classical generic products. Others conditions beyond the sole demonstration of in vivo bioequivalence should be satisfied to ensure prudent, i.e., without risk to the patient, therapeutic substitution.
Keywords
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Authors
J.-L. Prugnaud,