Clinical and scientific aspects related to biosimilars in inflammatory bowel diseases (IBD): position document of the Belgian IBD Research & Development Group (BIRD)
Baert, Filip; AZ Delta Roeselaere > Gastro-entérologie
Language :
English
Title :
Clinical and scientific aspects related to biosimilars in inflammatory bowel diseases (IBD): position document of the Belgian IBD Research & Development Group (BIRD)
Federal Agency for Medicines and Health Products (FAGG/AFMPS). Biosimilar Topic. http://www.fagg-afmps.be/en/human_use/medicines/medicines/MA_procedures/types/Biosimilars (consulted on 24-02-2014)
Weise M., Kurki P., Wolff -Holz E., Bielsky M. C., Schneider C. K. Biosimilars: the science of extrapolation. Blood, 2014, 124: 3191-6.
Park W., Hrycaj P., Jeka S., Kovalenk o V., Lysenko G., Miranda P., Mikazane H., Gutierrez-Ureña S., Lim M., Lee Y.A., Lee S.J., Kim H., Yoo D.H., Braun J. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann. Rheum. Dis., 2013, 72: 1605-12.
Yoo D.H., Hrycaj P., Miranda P., Ramiterre E., Piotrowski M., Shevchuk S., Kovalenko V., Prodanovic N., Abello-Banfi M., Gutierrez-Ureña S., Morales-Olazabal L., Tee M., Jimenez R., Zamani O., Lee S.J., Kim H., Park W., Müller-Ladner U. A randomised, double-blind, parallel- group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann. Rheum. Dis., 2013, 72: 1613-20.
Danese S., Gomollon F.; Governing Board and Operational Board of ECCO. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J. Crohns Colitis, 2013, 7: 586-9.
Argüelles -Arias F., Barreiro-de-Acosta M., Carballo F., Hinojosa J., Tejerina T. Joint position statement by “Sociedad Española de Patología Digestiva” (Spanish Society of Gastroenterology) and “Sociedad Española de Farmacología” (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. Rev. Esp. Enferm. Dig., 2013, 105: 37-43.
Mularczyk A., Gonciarz M., Bartnik W., Durlik M., Eder P., Gąsi orowska A., Linke K., Lodyga M., Lykowska -Szuber L., Małecka-Panas E., Pawlik M., Radwan P., Rydzewska G. Biosimilar medicines – their use in the treatment of inflammatory bowel diseases. Position statement of the Working Group of the Polish National Consultant in Gastroenterology. Prz. Gastroenterol., 2014, 9: 1-3. doi: 10.5114/pg.2014. 40842. Epub 2014 Mar 1.
Kay J., Feagan B.G., Guirguis M.S., Keystone E.C., Klein A.V., Lubiniecki A.S., Mould D.R., Nyarko K.A., Ridgway A.A., Trudeau M.E., Wang J. Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada, 14 May 2012. Biologicals, 2012, 40: 517-27.
