Biosimilar Monoclonal Antibodies in Latin America

GATTO, M.; HELGUERA, G.; BATTO, MARÍA V.; KARP, P.; FERRERO, S.

Biosimilars

IntechOpen

Lugar: London; Año: 2021; p. 1 - 27

In the last decade, the expiration of patents protecting therapeutic monoclonalantibodies opened an opportunity for the development and approval of biosimilarversions of these drugs. The complexity of these biologic molecules required theimposition of strict regulations to establish robust comparability with the antibodyof reference in physicochemical, analytical, biological and, when deemed necessary, clinical data. Accordingly, this period coincides with the updating of therequirements and guidelines for the manufacture and approval of biologics in LatinAmerican countries by their respective regulatory agencies. Although the term?biosimilar? does not appear in the official regulatory provisions in most of thecountries, it is of general use in Latin America, and several biosimilars of therapeuticmonoclonal antibodies were approved based on comparative quality, nonclinical andclinical data that demonstrate similarity to a licensed biological reference registeredbefore in a Regulatory Health Authority of reference. Here, we provide an overviewof how the complexities of therapeutic monoclonal antibodies shaped the regulatorylandscape of similar biologics, the current status of biosimilar monoclonal antibodiesin Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, México, Paraguay, Perú andUruguay and their potential to reduce the cost of antibody therapies in this region.