For small ââ?¬â?? low molecular weight ââ?¬â?? molecule medicines a robust regulatory system has evolved over the\nyears. This system guarantees high and constant quality of our (generic) medicines. Pharmaceutical\nequivalence and bioequivalence assessment are the pillars under that system. But there are complex\nmedicines where the question of equivalence is more challenging to answer. For biologicals the paradigm\nof similarity rather than equality (the emergence of ââ?¬Ë?biosimilarsââ?¬â?¢) was developed in the past decade. This\nhas been a program where an evolutionary, science based approach has been chosen by the frontrunner\nregulatory body, the EMA, with a ââ?¬Ë?learn and confirmââ?¬â?¢ character.\nIn addition, there is another group of complex drugs, the non-biological complex drugs, NBCDs, where\nthe generic paradigm can be challenged as well. The NBCDs are defined as: 1. consisting of a complex\nmultitude of closely related structures; 2. the entire multitude is the active pharmaceutical ingredient;\n3. the properties cannot be fully characterized by physicochemical analysis and 4. the consistent, tightly\ncontrolled manufacturing process is fundamental to reproduce the product. NBCDs encompass product\nfamilies such as the glatiramoids, liposomes, ironââ?¬â??carbohydrate colloids and many candidates of the\ngroup of the upcoming nanoparticulate systems. Following the main principles of regulatory pathways\nfor biologicals (with appropriate product-by-product adjustments), instead of that for small molecules,\nwould be the more logical strategy for these NBCDs.\nThe status and outstanding regulatory issues for biosimilars and NBCD-similars/follow on versions\nwere discussed at a conference in Budapest, Hungary (October 2014) and this commentary touches upon\nthe issues brought up in the presentations, deliberations and conclusions.
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