Comparability Pathway for the Approval of Similar Biologics with Respect to Reference Biologics in Europe and Brazil

Abstract

Abstract: The regulatory environment for biologics is continuously evolving, because they are ensuring the targeted therapies for many dreadful diseases. But the high cost of biologics has made the European Union to go for the biosimilar development for the first time after the expiration of patents. The strict requirements by the European Medicines Agency (EMA) guaranteed the highest quality standards. These biosimilars are complex in nature and difficult to characterize because they are extracted from the living sources and requires modern biotechnological methods that differ widely from the conventional drugs. The biosimilarity will be assessed based on the comparability studies where there should not be any traces of clinical differences in terms of quality, safety and efficacy. While the Brazil focused mainly on reducing the cost of biosimilar which are essential in treating many rare and specific diseases which lead to the PPD concept for the sake of the public health care system. Two regulatory pathways are emerged for the biosimilars in Brazil in which the molecules that were licensed through the comparability pathway are only considered as biosimilars. The present article summarizes the development process, regulatory perspectives of biosimilars and related issues that may occur due to interchangeability, extrapolation and International non-proprietary names in EMA, ANVISA and also mentioned about the benefits and purpose of Brazil National Health Surveillance Agency (ANVISA) Partnership for productive development (PPD) concept. Key words: Biologics, biosimilars, EMA, ANVISA, comparability, International non-proprietary name Partnership for productive development.