Position statement on approval of biosimilars in Latin America

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The Fifth Latin American Forum on Biosimilars (FLAB) was held in Brasilia, Brazil in 2015 with the theme of ‘Interchangeability and Automatic Substitution’.  Discussions centred on the approval of CT-P13, an infliximab biosimilar; and RTXM83, a proposed rituximab biosimilar, in both Brazil and Argentina. Following these discussions, Babini et al. [1] published a FLAB position statement on the approval of these monoclonal antibody biosimilars in the context of current regulations in these two Latin American countries.


Through critical analysis of the biosimilarity exercises carried out on the two products, the authors stated that CT-P13 is the only monoclonal antibody marketed in Latin America that can be considered a true biosimilar. CT-P13 underwent clinical trials and demonstrates clinical biosimiliarity to the reference product. Despite this, Babini et al. noted that biosimilarity does not mean guaranteed interchangeability. The biosimilar was tested in two disease models (ankylosing spondylitis (AS) and rheumatoid arthritis (RA), and was then extrapolated for the treatment of inflammatory bowel disease (IBD) in over 50 countries, including Brazil. This approval has been subject to debate, as it was based on extrapolation which is contrary to regulation in Brazil. FLAB position statement states, for interchangeability that ensures safe and effective treatment, further trials and evidence are needed to demonstrate that a biosimilar can produce similar effects to the reference product, for a given condition, in any given patient. Babini et al. reported that such a study has been proposed for CT-P13 [2].

Although clinical trials are underway, at present there is no clinical data available to demonstrate that RTXM83 is equivalent to its reference, rituximab. Babini et al. reported that this means that it is not a true biosimilar product. Despite the lack of clinical evidence and contrary to regulation, RTXM83 was approved as a biosimilar in Argentina. At present, it has not been approved in Brazil.

Babini et al. concluded that, to ensure the success of biosimilars and achieve a reduction in drug expenditure, there must be evidence that they achieve similar clinical results to their reference products. Countries in Latin America need to create well-defined pathways and regulations for the approval, review, and pharmacovigilance of biosimilars. To ensure appropriate approval and usage of biosimilars, governments should also ensure their actions are transparent and consistent with regulations in place.

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1. New monoclonal antibody biosimilars approved in 2015 in Latin America: position statement of the Latin American Forum on Biosimilars on biosimilarity, interchangeability and extrapolation of indications. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(2):66-9. doi:10.5639/gabij.2016.0502
2. GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator aplasia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 10]. Available from:

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