Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Requirements for Pharmaceuticals, Biotechnological Products, and Biosimilars in Latin America: Common Requirements and Differences

Dr. Christa Pfleiderer (Abschlußjahr: 2009)

Based on individual social and economic development of the Latin American countries national drug registration frameworks have evolved independently according to the national requirements to provide primary health care. Due to globalization of the pharmaceutical market Latin American countries started to revise their regulatory registration pathways and adopted international standards especially for biopharmaceuticals and biosimilars.

Latin America consists of 48 countries and territories with an overall population of more than 570 million estimated in 2008. Four countries in Latin America (Brazil, Mexico, Argentina and Venezuela) belong to the 30 largest pharmaceuticals markets worldwide. Moreover three countries in the region, Argentina, Brazil, and Mexico are producing large quantities of pharmaceutical products, thus acting as important suppliers for the region.

Due to economic pressures as well as to urgently required improvements of primary health care systems generic pharmaceuticals were approved and marketed in Latin America long before local Intellectual Property Rights were established. As a result of late implementation of the appropriate Intellectual Property standards it was not possible in Latin America to adopt the classical definition of generics. Therefore the term generic is used differently in Latin America and has different meanings within individual countries depending on the context within the term is used.

Harmonization of regulatory frameworks has not yet taken place in Latin America. Consequently regulatory legislation is varying to a great extent from country to country with regard to drug classification, dossier requirements and review process set by the national health authorities. However there are several on-going harmonization initiatives, mainly driven by economic organizations, but also driven by the Pan American Health Organization (PAHO). One of the pivotal consequences of late adoption of Intellectual Property Rights and as well as of delayed implementation of data exclusivity laws was the registration of generic versions of biopharmaceuticals under the generic framework in some Latin American countries. Concerns which arose in parallel to the development of first biosimilars in ICH-countries also started discussion about biosimilars in Latin America. As a consequence, some of the Latin American countries (Venezuela, Brazil, and Mexico) have already revised their regulation for biologicals/biosimilars during the recent years. Brazil is the lead country with regard to biopharmaceuticals/biosimilar regulation and is therefore expected to become an important entry point for the import of biopharmaceuticals/biosimilars to the Latin American market. Likewise, Mexico has revised in 2009 its regulatory framework for the registration of biosimilars. Argentinean legislation facilitates very straight-forwardly registration of copied biopharmaceuticals, yet it is expected that Argentina will adopt international standards for the registration of biosimilars in order to support the strong local biotech industry and to afford export. Although registration of biologics and biosimilars is not explicitly regulated in Colombia each biological product must provide its own safety and efficacy data.

Currently, a WHO guideline defining standards for registration requirements for biosimilars is under discussion and after finalization of this guideline it is expected that more countries in Latin America will revise their regulatory framework for registration of biopharmaceuticals and biosimilars accordingly.

Pages: 60