Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Diversity of regulatory requirements for the approval of biosimilars in the LATAM region: Comparison of the WHO guidance with the available guidelines/regulations in Chile, Brazil and Colombia ***

Dr. Robert Mühlbacher (Abschlußjahr: 2016)

Summary
Language: English
In the context of the growing cost pressure on health markets, health agencies all over the world view biosimilars as a means to reduce costs and facilitate the access to affordable efficacious medication. In order to ensure quality, safety and efficacy of these products, health authorities have started to establish regulatory standards, many of them adopting the general principles of the WHO guidelines for biosimilar products. Consequently, biosimilar products have also gained an increasing attractiveness in Latin America. Several governments in Latin America have already implemented specific regulations or guidance documents for the registration of these products.
This master thesis describes and discusses the diversity of regulatory requirements for the licensure of biosimilars in Latin America by comparing the established regulations/guidelines in Brazil, Chile and Colombia with the internationally accepted "WHO standards for biosimilar products". The analysis of these regulatory requirements reveals significantly different regulatory standards in the three countries and reflects the diversity of standards among the Latin American countries. Although there is a general tendency to follow and implement the WHO guidelines, different levels of evidence as well as alternative regulatory pathways with less stringent, vague or undefined requirements for the approval of biosimilar products remain a considerable challenge in Latin America. To ensure that biosimilar products follow same standards in terms of quality, efficacy and safety, big efforts will still be necessary by the regulatory authorities to further harmonize and strengthen the regulatory standards in Latin America. In addition, the implementation of effective pharmacovigilance systems will be required, thus contributing to a better protection of public health and patient safety.
Pages: 60