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

摘要

Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual meeting that brings together various stakeholders,including key opinion leaders, the pharmaceutical industry, academics, patients, lawyers and other healthcare professionals, topresent and discuss recent findings regarding biosimilars. In 2015, the meeting theme was interchangeability and automaticsubstitution. Regarding biosimilarity, interchangeability and extrapolation of indications, the discussion centred on two products inBrazil and Argentina: CT-P13, an infliximab biosimilar? and RTXM83, a rituximab biosimilar. Here, we conduct a critical analysis of theavailable scientific and medical information on these products to establish a FLAB position statement in the context of the currentregulations in Brazil and Argentina.Biosimilarity, interchangeability and extrapolation of indications: RTXM83 is still not approved in Brazil and is currently under atechnology transfer agreement. In Argentina, the drug was approved for commercialization under the name Novex, with extrapolationof indications for rheumatoid arthritis, which according to the Argentinian Society of Rheumatology, lacks the necessary clinical data forsuch an approval. CT-P13 is already approved in Brazil, and is on the market. The approval was based on the data presented in thePLANETAS and PLANETRA studies. Interchangeability will not be considered for this product until further studies are presented.Discussion: Based on the available evidence, CT-P13 is the only biological molecule marketed in Latin America that can beconsidered a true biosimilar. Extrapolation is only acceptable when the diseases for which the reference product is intended to treatare entirely similar. Extrapolation based on only preclinical studies is not acceptable. Conversely, although the proposed rituximabbiosimilar (RTXM83) was approved by ANMAT (National Administration for Medicines, Food and Medical Technology) in Argentina,clinical data demonstrating its equivalence with the reference rituximab, is necessary before RTXM83 can be considered a truebiosimilar.