Year 2013 / Volume 105 / Number 1
Puntos De Vista
Joint position statement by “Sociedad Española de Patología Digestiva” (Spanish Society of Gastroenterology) and “Sociedad Española de Farmacología” (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease

pp. 37-43

Federico Argüelles-Arias, Manuel Barreiro-de-Acosta, Fernando Carballo, Joaquín Hinojosa and Teresa Tejerina

Abstract
Biological drugs or biopharmaceutical products, manufactured with or from living organisms using biotechnology, have represented a therapeutic revolution for the control of inflammatory bowel disease (IBD). At present, in this indication and in our country, only two bio- logicals are approved, infliximab (IFX) and adalimumab (ADA), both of them monoclonal antibodies against tumor necrosis factor alpha. Effectiveness data are strong for both therapies, with maximum levels of scientific evidence.
The upcoming expiry date for these biologicals’ patents has allowed the potential marketing of so-called biosimilar agents for the IBD indication. While biosimilars are conceptually for biologicals what generics are for chemical drugs, the structural complexity of biosimilars and their biological and manufacturing variability lead to consider validation processes for these two types in humans as highly differential. Thus, in our setting, under the coverage of “Agencia Española del Medicamento y Productos Sanitarios (AEMPS)” (Span- ish Agency of Medicines and Medical Devices), guidelines issued by the European Medicines Agency (EMA) are to be applied, which states that a number of stages or steps must be overcome in order to obtain approval for a biosimilar agent.
However, despite the presence of these recommendations by EMA, which must be met by a biosimilar in order to be licensed in our marketplace, relevant uncertainties persist that only future deci- sions by EMA and AEMPS may clarify. The present stance by our task force is that biosimilar development should be undertaken according to established regulations, thus certifying their efficacy and safety. Similarly, this task force considers that results obtained from studies in rheumatoid arthritis (RA) should not be extrapolated to IBD since the biological variability of these complex structures will not ensure a lack of noticeable changes in efficacy and safety.
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28/04/2013 19:41:26
Por la presente, los autores del Posicionamiento quieren manifestar su independencia absoluta en la redacción de dicho artículo y declaran haberlo firmado en nombre de la Sociedad Española de Aparato Digestivo y de la Sociedad Española de Farmacología.
Como especialistas en Aparato Digestivo, los doctores Federico Argüelles-Arias, Manuel Barreiro-Acosta, Joaquin Hinojosa y Fernando Carballo han participado en reuniones, cursos y en proyectos de formación promovidas por las compañías que comercializan actualmente los Biológicos en nuestro país si bien, para la redacción de este artículo declaran no haber tenido ningún conflicto de interés y haber actuado con total independencia de estas compañías o de cualquier otra con interés en los fármacos denominados biosimilares. Lo mismo cabe manifestar de la doctora Teresa Tejerina que firma en representación y como presidenta de la Sociedad Española de Farmacología.
Por tanto, sirva este escrito para suscribir y ratificar las opiniones vertidas en dicho artículo.

Fdo: Dr. Federico Argüelles-Arias en nombre de los autores del documento y como Secretario de la SEPD.


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Federico Argüelles-Arias, Manuel Barreiro-de-Acosta, Fernando Carballo, Joaquín Hinojosa and Teresa Tejerina. Joint position statement by “Sociedad Española de Patología Digestiva” (Spanish Society of Gastroenterology) and “Sociedad Española de Farmacología” (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. 37-43


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