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Systematic Review ARTICLE Provisionally accepted The full-text will be published soon. Notify me

Front. Pharmacol. | doi: 10.3389/fphar.2019.01010

Efficacy and safety in the continued treatment with a biosimilar drug in patients receiving Infliximab: use of a systematic review in the context of decision making from a Latin-American country

 Edward Mezones-Holguin1*, Rocio V. Gamboa-Cardenas2, Gadwyn Sanchez-Felix3, José Chávez-Corrales4,  Luis M. Helguero-Santin5, L Max Laban-Seminario5,  Paula A. Burela-Prado6,  Maribel M. Castro-Reyes6 and Fabian Fiestas6
  • 1Centro de Excelencia en Estudios Económicos y Sociales en Salud, Universidad San Ignacio de Loyola, Peru
  • 2Hospital Nacional Guillermo Almenara Irigoyen, Servicio de Reumatologia, Social Security of Health (EsSALUD), Peru
  • 3Hospital Nacional Edgardo Rebagliati Martins, Servicio de Dermatología, Social Security of Health (EsSALUD), Peru
  • 4Hospital Nacional Edgardo Rebagliati Martins, Servicio de Reumatologia, Social Security of Health (EsSALUD), Peru
  • 5Facultad de Ciencias de la Salud, Sociedad Científica de Estudiantes de Medicina (SOCIEMUNP), National University of Piura, Peru
  • 6Instituto de Evaluación de Tecnologías Sanitarias e Investigación (IETSI), Social Security of Health (EsSALUD), Peru

Introduction: Biological products, including infliximab, are a therapeutic option for various medical conditions. Biosimilars are a safe, effective and approved alternative for these conditions in affiliated patients to start treatment with Infliximab. However, there is a group of patients who receive treatment with the biological reference products (PBR), in whom the possibility of continuing their therapeutic regimen with a biosimilar biological product (PBB) must be assessed.
Methodology: We conducted a systematic review of controlled randomized studies regarding the continuation of biosimilar therapy in patients receiving the original Infliximab under the approved conditions of use for EsSalud. We performed search in Pubmed-MEDLINE, SCOPUS, WOS, EMBASE, TRIPDATABASE, DARE, Cochrane Library, NICE, AHRQ, SMC, McMaster-PLUS, CADTH, y HSE until June 2018. We use the Cochrane tool to assess the risk of bias.
Results: A total of 1136 records were identified in the primary search, we removed 337 duplicates. From the 799 screened records, we excluded 785. Of the 14 documents evaluated in full text, we included five Clinical Trials. The PBR CTP-13 was evaluated in four studies, while the remaining research evaluated the biosimilar SB2. Two trials were double-blind and reported no differences in terms of efficacy and safety in patients who switched from PBR to PBB versus those who maintained treatment with PBR for all medical conditions evaluated (CTP-13) and for rheumatoid arthritis. While the three remaining studies were an extension to open label primary clinical trials in which no differences were reported in terms of efficacy and safety in people who initially received the PBR and switched to a biosimilar, compared to those who maintained their treatment with PBB.
Conclusions: Outside of the limitations of the primary studies included, the evidence shows that there were no differences regarding the net benefit of continuing the treatment with the original Infliximab or exchanging its biosimilar component in terms of efficacy and safety. Based on the opportunity cost principle, the exchange of a biosimilar in patients receiving the original Infliximab is a valid therapeutic alternative with a good efficacy and safety profile.

Keywords: infliximab, Biosimilar agent, Interchangeability of drugs, decision making, Peru

Received: 16 Feb 2019; Accepted: 08 Aug 2019.

Edited by:

Marcus T. Silva, Federal University of Amazonas, Brazil

Reviewed by:

Alexandros A. Drosos, University of Ioannina, Greece
Hillel Cohen, Sandoz Inc., United States  

Copyright: © 2019 Mezones-Holguin, Gamboa-Cardenas, Sanchez-Felix, Chávez-Corrales, Helguero-Santin, Laban-Seminario, Burela-Prado, Castro-Reyes and Fiestas. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Prof. Edward Mezones-Holguin, Universidad San Ignacio de Loyola, Centro de Excelencia en Estudios Económicos y Sociales en Salud, Lima, Peru,