This chapter provides an overview of the challenges facing the pharmaceutical industry in Brazil, including the regulatory framework for generics, similars and biosimilars, the exponential growth of the market, the problems still existing in the competition with non-interchangeable copies (similars) and the absence of compliance with international standards, to date. The Brazilian government policies to favour domestic pharmaceutical industries and the country's lack of clear rules regarding the purchasing preferences, with its recently enacted government purchasing programme, are also covered.

This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.