Development of Biosimilars in Brazil

Abstract

This article presents a brief overview of the biosimilar industry in Brazil and in the world. Biosimilars are drugs originating from therapeutic or biological proteins, whose patents are expired or are going to expire. Similarly to the generic pharmaceutical industry, the expiration of patents for biologics allows the emergence of a new segment in the pharmaceutical companies. The advent of biosimilars enables to overcome of several barriers, not limited to regulatory aspects of intellectual property, but also issues related to process and technological expertise. At this level of complexity, the biosimilar manufacturers need to have the same expertise or capabilities compared to originator drug companies or holders of the patents. The importance of biosimilars is due to public health context and high costs of originator biologics. Due to an aging population, the incidence of chronic degenerative disease will increase and will have a major impact in healthcare system, in this way the emergence of biosimilars will result in substantial cost reductions.