From bioequivalence to biosimilars: How much do regulators dare?

From bioequivalence to biosimilars: How much do regulators dare? Z Evid Fortbild Qual Gesundhwes. 2019 Jan 06;: Authors: Weise M Abstract The main advantage of an abbreviated licensing pathway is the possibility of extrapolating efficacy and safety data from an original medicinal product to a subsequent "copy" version, thereby reducing the clinical development programme in particular. For small-molecule chemically synthesized generics, such an abbreviated licensing pathway was established decades ago, whereas it was only more recently implemented for similar biological medicinal products, so-called biosimilars. Clinicians and patients have repeatedly expressed concerns about the efficacy and safety of biosimilars, especially in 'extrapolated' indications for which no own clinical data have been generated. Generic drugs usually contain well-defined active ingredients whose "identity" with that of the originator, the so-called reference product, is easily verifiable. Biological substances are generally more complex and difficult to characterize. They are produced in living organisms and therefore naturally exhibit some intrinsic variability, i.e. microheterogeneity. Since the chosen expression system and the manufacturing conditions influence the quality characteristics of a biological substance, mostly its posttranslational modifications such as the glycosylation pattern, it is unlikely that two independent manufacturing processes can...
Source: Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen - Category: Health Management Tags: Z Evid Fortbild Qual Gesundhwes Source Type: research