La inflammatory bowel disease (IBD) It is characterized by chronic inflammation of the digestive tract, its most common pathologies being Crohn's disease (CD) and ulcerative colitis (UC). Thus, while in the former the inflammation can be anywhere in the digestive system, in the case of UC it only affects the large intestine or colon.
Between 84.000 and 120.000 people suffer from IBD in SpainTherefore, one in every 450 people in our country suffers from these problems, according to estimates by the Spanish Society of Digestive Pathology despite the absence of an official patient registry.
Of this total, 42% have the Crohn's disease and 48% suffer ulcerative colitis. However, the organization anticipates a rise in the prevalence of these chronic diseases in the coming years, a boom that will also be reflected at the economic level.
The report 'Inflammatory Bowel Disease current situation and healthcare challenges', prepared by the EY Life Sciences Research Center, indicates that the economic impact of IBD is 1.083 million euros in Spain, of which 46,5% corresponds to indirect costs derived from work disability that causes the disease.
Today Infliximab biosimilar is approved for use in inflammatory bowel disease (the parent drug is Remicade) since September 2013, under two trade names: Inflectra y Remsima. The indications of biosimilars with infliximab are the same as those of the reference medicine and it is administered in the same way, intravenously and at the same doses. In light of the exhaustive analytical and clinical evidence, the European Medicines Agency (EMA), the most experienced in the development of regulations and in the evaluation of biosimilars, estimated that the performance of biosimilars and the original product, Remicade, was the same. same for any of the indications.
Infliximab It is often used in patients diagnosed with Crohn's disease o ulcerative colitis with a moderate or severe outbreak and that does not respond favorably to conventional treatments or when these are contraindicated or there is intolerance.
Last year, an independent and prospective study carried out in Hungary found that the response in patients treated with the biosimilar was similar to that expected with the reference biologic in terms of induction and maintenance of remission. In addition, after testing the first 90 biosimilar patients, significant reductions in validated indicators of disease activity were observed compared to baseline after two and six weeks of treatment. Also, the concentrations of C-reactive protein (CRP) decreased during induction therapy for ulcerative colitis.