Abstract
In the last decade, the expiration of patents protecting therapeutic monoclonal antibodies opened an opportunity for the development and approval of biosimilar versions of these drugs. The complexity of these biologic molecules required the imposition of strict regulations to establish robust comparability with the antibody of reference in physicochemical, analytical, biological and, when deemed necessary, clinical data. Accordingly, this period coincides with the updating of the requirements and guidelines for the manufacture and approval of biologics in Latin American countries by their respective regulatory agencies. Although the term “biosimilar” does not appear in the official regulatory provisions in most of the countries, it is of general use in Latin America, and several biosimilars of therapeutic monoclonal antibodies were approved based on comparative quality, nonclinical and clinical data that demonstrate similarity to a licensed biological reference registered before in a Regulatory Health Authority of reference. Here, we provide an overview of how the complexities of therapeutic monoclonal antibodies shaped the regulatory landscape of similar biologics, the current status of biosimilar monoclonal antibodies in Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, México, Paraguay, Perú and Uruguay and their potential to reduce the cost of antibody therapies in this region.
Highlights
1.1 The evolution of monoclonal antibodies to biologic medicinesAntibodies, known as immunoglobulins, are complex glycoproteins produced by B-cells against foreign substances as part of the adaptive immune response [1, 2]
Several biosimilars of rituximab have been developed over the years, and by 2021 there are five different biosimilars of rituximab approved in Latin America, with nine different brand names commercialized in Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Paraguay, Peru and Uruguay (Table 1)
In 2021, there are a total of four different trastuzumab biosimilars approved in Latin America, with seven different brand names marketed in Argentina, Brazil, Colombia and Peru (Table 1)
Summary
Antibodies, known as immunoglobulins, are complex glycoproteins produced by B-cells against foreign substances as part of the adaptive immune response [1, 2]. Biosimilars have only murine sequences, in human patients they exhibited limited effector function [5], were immunogenic inducing anti-mouse antibodies, and had a significantly reduced half-life [6] It was not until the development of recombinant monoclonal antibodies in the 1980s and 1990s that a new era of biologic therapy began, with the chimerical [7], humanized [8] and fully human antibodies [9]. Each step involved the gradual replacement of murine segments of the antibody sequence by the corresponding human sequence: in chimeric antibodies the constant region was replaced, and in humanized antibodies, the framework flanking the complementarity-determining regions and the constant region were replaced, and in human monoclonal antibodies the whole sequence is human Further engineering allowed their customization, creating variants in valence, size, effector functions and with the conjugation of compounds for delivery to targeted cell types such as cancer
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