%0 Journal Article
%T Joint position statement by "Sociedad Espa ola de Patolog赤a Digestiva" (Spanish Society of Gastroenterology) and "Sociedad Espa ola de Farmacolog赤a" (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease Posici車n conjunta de la Sociedad Espa ola de Patolog赤a Digestiva y de la Sociedad Espa ola de Farmacolog赤a sobre el tratamiento con biosimilares en la enfermedad inflamatoria intestinal
%A Federico Arg邦elles-Arias
%A Manuel Barreiro-de-Acosta
%A Fernando Carballo
%A Joaqu赤n Hinojosa
%J Revista Espaˋola de Enfermedades Digestivas
%D 2013
%I The Spanish Society of Digestive Pathology
%X 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 biologicals 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 Espa ola del Medicamento y Productos Sanitarios (AEMPS)" (Spanish 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 decisions 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. Los productos biofarmac谷uticos, o medicamentos biol車gicos, fabricados mediante, o a partir de organismos vivos utilizando biotecnolog赤a, han supuesto una revoluci車n terap谷utica en el control de la enfermedad inflamatoria intestinal (EII). Al presente, en esta indicaci車n y en nuestro pa赤s, solo se dispone de dos biol車gicos autorizados, infliximab (IFX) y adalimumab (ADA), ambos anticuerpos monoclonales frente al factor de necrosis tumoral alfa. La evidencia de eficacia con ambos tratamientos es s車lida con niveles de evidencia cient赤fica m芍xima. La proximidad de la expiraci車n de las patentes de estos dos biol車gicos ha abierto la posibilidad de entrada en el me
%K Enfermedad inflamatoria intestinal
%K Enfermedad de Crohn
%K Colitis ulcerosa
%K Biosimilares
%K Infliximab
%K Adalimumab
%K Sociedad Espa ola de Patolog赤a Digestiva
%K Inflammatory bowel disease
%K Crohn's disease
%K Ulcerative colitis
%K Biosimilairs
%K Infliximab
%K Adalimumab
%K Spanish Society of Gastroenterology
%U http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1130-01082013000100006