Drug Brand Switching: A Regulatory Perspective

Résumé fourni par la source

The replacement of expensive medications marketed by companies that bore the cost of development and testing, by low-cost “generics” once patent protection ends, is a common step in the life cycle of most drugs. Although generics are required to meet strict bioequivalence standards, the introduction of first time and subsequent generics may lead to anxiety and increased reports of adverse effects or therapeutic failure. Whether these are real or imagined by those using them, can be challenging to assess. With the ongoing debate, this paper primarily explores how the regulatory framework governing generic drug approval may have contributed to this medical conundrum. In addition, we also offer a perspective on the potential role of pharmacogenetics within this setting.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.