TY - JOUR JO - Gastroenterology Review/Przegląd Gastroenterologiczny SN - 1895-5770 VL - 9 IS - 1 PY - 2014 ID - Mularczyk2014 TI - Biosimilar medicines – their use in the treatment of inflammatory bowel diseases. Position statement of the Working Group of the Polish National Consultant in Gastroenterology AB - 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. AU - Mularczyk, Aldona AU - Gonciarz, Maciej AU - Bartnik, Witold AU - Durlik, Marek AU - Eder, Piotr AU - Gąsiorowska, Anita AU - Linke, Krzysztof AU - Łodyga, Michał AU - Łykowska-Szuber, Liliana AU - Małecka-Panas, Ewa AU - Pawlik, Magdalena AU - Radwan, Piotr AU - Rydzewska, Grażyna SP - 1 EP - 3 DA - 2014 DO - 10.5114/pg.2014.40842 UR - http://dx.doi.org/10.5114/pg.2014.40842 ER -