title: Biosimilar medicines - their use in the treatment of inflammatory bowel diseases. Position statement of the Working Group of the Polish National Consultant in Gastroenterology.
abstract: Biological medical products are drugs whose active components are produced only by living, genetically modified organisms or live cell cultures. Patents and exclusivity for most biopharmaceuticals has either expired or will expire soon, which enables biotechnological companies to introduce similar biological products. The problem of replacing a biological medicine with a biosimilar in the course of therapy remains open. In this statement, the Working Group of the Polish National Consultant in Gastroenterology, in the absence of data regarding bioequivalence in patients with inflammatory bowel disease, does not recommend switching from original biological medicine to its biosimilar analogue in the course of treatment in inflammatory disease patients; however, this may change after receiving the results of controlled studies regarding bioequivalence in this group.
authors.affiliation: Department of Gastroenterology and Digestive Oncology, St. Barbara's Main District Hospital, Sosnowiec, Poland.
authors.forename: Aldona
authors.initials: A
authors.lastname: Mularczyk
authors.affiliation: Department of Gastroenterology and Digestive Oncology, St. Barbara's Main District Hospital, Sosnowiec, Poland.
authors.forename: Maciej
authors.initials: M
authors.lastname: Gonciarz
authors.affiliation: Department of Gastroenterology, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.
authors.forename: Witold
authors.initials: W
authors.lastname: Bartnik
authors.affiliation: Department of Surgical Research and Transplantology, Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland ; Department of Gastroenterology and Transplantology Surgery, Central Clinical Hospital of the Ministry of the Internal Affairs, Warsaw, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Durlik
authors.affiliation: Department of Gastroenterology, Human Nutrition and Internal Diseases, Poznan University of Medical Sciences, Poznan, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Eder
authors.affiliation: Department of Digestive Tract Diseases, Medical University of Lodz, Lodz, Poland.
authors.forename: Anita
authors.initials: A
authors.lastname: Gąsiorowska
authors.affiliation: Department of Gastroenterology, Human Nutrition and Internal Diseases, Poznan University of Medical Sciences, Poznan, Poland.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Linke
authors.affiliation: Department of Gastroenterology, Central Clinical Hospital of the Ministry of the Internal Affairs, Warsaw, Poland.
authors.forename: Michał
authors.initials: M
authors.lastname: Lodyga
authors.affiliation: Department of Gastroenterology, Human Nutrition and Internal Diseases, Poznan University of Medical Sciences, Poznan, Poland.
authors.forename: Liliana
authors.initials: L
authors.lastname: Lykowska-Szuber
authors.affiliation: Department of Digestive Tract Diseases, Medical University of Lodz, Lodz, Poland.
authors.forename: Ewa
authors.initials: E
authors.lastname: Małecka-Panas
authors.affiliation: Department of Gastroenterology, Central Clinical Hospital of the Ministry of the Internal Affairs, Warsaw, Poland.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Pawlik
authors.affiliation: Department of Internal Medicine and Internal Medicine in Nursing, Medical University of Lublin, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Radwan
authors.affiliation: Department of Gastroenterology, Central Clinical Hospital of the Ministry of the Internal Affairs, Warsaw, Poland ; Faculty of Sciences, University of Jan Kochanowski (UJK), Kielce, Poland.
authors.forename: Grażyna
authors.initials: G
authors.lastname: Rydzewska
keywords: biosimilar medicines; inflammatory bowel disease