Details

Autor(en) / Beteiligte

• Wolf, Douglas C

Titel

Biosimilars in Crohn's Disease and Ulcerative Colitis

Ist Teil von

• Inflammatory bowel diseases, 2016-04, Vol.22 (4), p.994-997

Ort / Verlag

United States

Erscheinungsjahr

2016

Link zum Volltext

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• On August 24, 1998, infliximab, an antibody to tumor necrosis factor alpha (anti-TNF) became the first biologic approved for inflammatory bowel disease (IBD). At that time, the approval was limited to induction therapy for moderate to severe luminal and fistulizing Crohn's disease; no Federal Drug Agency (FDA) approval for maintenance therapy was given. The anti-TNFs have changed the course of Crohn's disease and ulcerative colitis for many patients over the past 17 years. The benefit derived from these biologic drugs, the induction and maintenance of response and remission, and improvement of quality of life, are well known. With the advent of biosimilars, a new type of biologic has arrived. Biosimilars are biological medicines that are developed after the patent on a reference biologic has expired.1 Biosimilars to infliximab have been approved by the European Medicines Agency (EMA) and used in European countries. They are now being considered for approval by the FDA.2