Analyzing Biosimilars in Brazil: Comprehensive Specifications of the Regulatory System

Abstract: The largest nation in South America, Brazil, is now the world's second-largest market for pharmaceuticals thanks to country's economic growth. Brazilian Health Surveillance Agency, also known as National Agency (Agencia Nacional de Vigilancia Sanitaria - ANVISA), was founded 1999 with primary objective of protecting and strengthening public health surveillance over products services. Biological products, biopharmaceuticals, are medications that derived from biological systems then created utilizing contemporary biotechnological techniques. These very different traditional synthetic drugs a number important respects. Biosimilars required satisfy variety regulatory requirements before being given permission enter various regions. Other issues related this need be established by national authorities. include interchangeability, labelling, prescription information. monitoring agency follows fundamental criteria World Organization evaluating bio-similarity; nevertheless, it does not make use name "biosimilar." article present biosimilar law. Keywords: ANVISA, Regulations, Guidelines, Biosimilars, Pathway.