Regulatory framework and disparities of complex generics in United States, European Union & Latin America

Abstract

The regulatory agencies all over the world have defined the pathway and the regulations for approval of simple small-molecule generics. In addition, the agencies are striving to form perspicuous regulatory frameworks for approval of biosimilar. According to this viewpoint, the approval of complex generics, also known as non-biological complex pharmaceuticals, is not subject to any clearly defined regulations (NBCDs). Although they differ from biologic products, complex medicines are constructed of huge, extremely complex, and synthetic components. The regulatory frameworks that are currently being used for complicated generics are opaque and uncertain. The market for complex generics is huge and there are fewer generic competitors in this area. In addition, the cost of bringing such generics into the market is high. Thus, there is a need for a well-defined pathway and guidance documents for the authorization of generic versions of complex drug products. The paper focus on the regulatory frameworks that the USA, EU, and Latin America have developed at this time to allow for the introduction of complicated generics to the market. In order to analyse regulatory policies in the USA, Europe, and Latin America for the marketing of NBCD copies, a case study of a product with an approved generic version is used. It also describes on the regulatory disparities existing among the three agencies in the light of complex generics.