Abstract:
High-barrier-to-entry generic drugs are difficult to make because of the relatively complex product design. Requirements of specification and bioequivalence are difficult to meet if the product is not fully understood and controlled. Currently, the accessibility of high-barrier-to-entry drug products in China's market is low. However, the country' s environment of encouraging innovation provides a good opportunity for the pharmaceutical industry to increase the accessibility of such generic products. Generic metoprolol succinate extended release (MPS ER) tablets are difficult to develop and manufacture. The formulation characteristics, technical challenges, regulatory requirements, and development results for Novast's FDA approved MPS ER tablet are summarized in this paper, serving as a case study for the development and review of high-barrier-to-entry generics in China.
下载: