Patricia Socualaya Sotomayor

Title: Regulation and advances of Biosimilars in Latin America
Time: 11:45 - 12:15


Patricia Socualaya Sotomayor is a physician and graduated of Master of Clinical Epidemiology and Master of Health Management in UPCH - Peru. Clinical reviewer of biologics and biosimilars at Medicines Regulatory Authority of Peru (DIGEMID – Ministry of Health of Peru). Teacher's assistant in the Undergraduate Program of the Faculty of Medicine - UPCH, in the courses of Methodology of Research and Clinical Epidemiology. She has competence in the evaluation of clinical studies for the authorization of biologicals and biosimilars; and interest in the regulation of this kind of products.

Research Interest


Statement of the Problem: In recent years, biosimilars have been a focus of attention and a convenient option for disease treatment costs in Latin America. Methodology & Theoretical Orientation: Information was compiled on the regulatory framework that led to the regulatory development of biosimilars published on the websites of the Latin American Medicines Regulatory Authorities. A bibliographic search was also conducted on PubMed and Scielo using the key terms related to the regulation of biosimilars in Latin America. In some cases, the Drug Regulatory Agencies were consulted on the topics in question, in order to corroborate the information. The information collected was classified according to year of publication. Subsequently, they proceeded to analyze and compare according to the aspects of comparability studies, extrapolation of indications, interchangeability, nomenclature biosimilars and aspects of pharmacovigilance. Findings: A biosimilar standard was found published in 50% (14/28) of Latin American   

(Figure 1. In green the countries that have biosimilar regulation).

The regulatory development of biosimilars began with Brazil (in 2010), followed by Mexico, Argentina and Costa Rica (in 2012), Venezuela and Ecuador (in 2013), Chile and Colombia (in 2014), Cuba, Uruguay and Guatemala (in 2015), Dominican Republic and Peru (in 2016) and Paraguay (in 2017). Regulation of biosimilars in Latin America varies widely among countries and others have not yet introduced a standard for biosimilars. As for interchangeability, only Brazil has pronounced itself, which considers it to be directly related to clinical practice than to a regulatory state and implies broader aspects for its evaluation.  Conclusion & Significance: Most of the Drug Regulatory Agencies have adopted the recommendations of the World Health Organization, however it is necessary to harmonize the regulation of biosimilars and involve the government, the pharmaceutical industry, academia, health professionals and patients.