The use of biosimilars in immune-mediated disease: A joint Italian Society of Rheumatology (SIR), Italian Society of Dermatology (SIDeMaST), and Italian Group of Inflammatory Bowel Disease (IG-IBD) position paper
作者： Gionata Fiorino , Giampiero Girolomoni , Giovanni Lapadula , Ambrogio Orlando , Silvio Danese
DOI: 10.1016/J.AUTREV.2014.02.004
关键词: Inflammatory bowel disease 、 Arthritis 、 Biosimilar 、 Medicine 、 Psoriatic arthritis 、 Rheumatology 、 European union 、 Psoriasis 、 Internal medicine 、 Dermatology 、 Ankylosing spondylitis
摘要: … in clinical studies with a limited sample size, particularly when the biosimilar differs from the … EMA has recently designated a biosimilar as automatically substitutable, although each …
core.ac.uk
elsevier.com
sci-hub.se 参考文章(34)
Mirhelen Mendes de Abreu, Vibeke Strand, Roger Abramino Levy, Denizar Vianna Araujo, Putting the value into biosimilar decision making Autoimmunity Reviews. ,vol. 13, pp. 678- 684 ,(2014) , 10.1016/J.AUTREV.2014.01.051
George Dranitsaris, Eitan Amir, Kristine Dorward, None, Biosimilars of Biological Drug Therapies Regulatory, Clinical and Commercial Considerations Drugs. ,vol. 71, pp. 1527- 1536 ,(2011) , 10.2165/11593730-000000000-00000
Martina Weise, Marie-Christine Bielsky, Karen De Smet, Falk Ehmann, Niklas Ekman, Gopalan Narayanan, Hans-Karl Heim, Esa Heinonen, Kowid Ho, Robin Thorpe, Camille Vleminckx, Meenu Wadhwa, Christian K Schneider, Biosimilars-why terminology matters. Nature Biotechnology. ,vol. 29, pp. 690- 693 ,(2011) , 10.1038/NBT.1936
S Cazzaniga, S Chimenti, A Giannetti, M Maccarone, M Picardo, G Girolomoni, L Naldi, Psocare Study Group, None, Metabolic abnormalities associated with initiation of systemic treatment for psoriasis: evidence from the Italian Psocare Registry. Journal of The European Academy of Dermatology and Venereology. ,vol. 27, pp. 30- 41 ,(2013) , 10.1111/J.1468-3083.2012.04450.X
Giovanni Lapadula, Gian Franco Ferraccioli, Biosimilars in rheumatology: pharmacological and pharmacoeconomic issues. Clinical and Experimental Rheumatology. ,vol. 30, ,(2012)
Martina Weise, Marie-Christine Bielsky, Karen De Smet, Falk Ehmann, Niklas Ekman, Thijs J. Giezen, Iordanis Gravanis, Hans-Karl Heim, Esa Heinonen, Kowid Ho, Alexandre Moreau, Gopalan Narayanan, Nanna A. Kruse, Gabriele Reichmann, Robin Thorpe, Leon van Aerts, Camille Vleminckx, Meenu Wadhwa, Christian K. Schneider, Biosimilars: what clinicians should know. Blood. ,vol. 120, pp. 5111- 5117 ,(2012) , 10.1182/BLOOD-2012-04-425744
Astrid Wiens, Rafael Venson, Cassyano J Correr, Michel Fleith Otuki, Roberto Pontarolo, Meta‐analysis of the Efficacy and Safety of Adalimumab, Etanercept, and Infliximab for the Treatment of Rheumatoid Arthritis Pharmacotherapy. ,vol. 30, pp. 339- 353 ,(2010) , 10.1592/PHCO.30.4.339
Daniel Tracey, Lars Klareskog, Eric H. Sasso, Jochen G. Salfeld, Paul P. Tak, Tumor necrosis factor antagonist mechanisms of action: A comprehensive review Pharmacology & Therapeutics. ,vol. 117, pp. 244- 279 ,(2008) , 10.1016/J.PHARMTHERA.2007.10.001
Filip Baert, Maja Noman, Severine Vermeire, Gert Van Assche, Geert D' Haens, An Carbonez, Paul Rutgeerts, Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. The New England Journal of Medicine. ,vol. 348, pp. 601- 608 ,(2003) , 10.1056/NEJMOA020888
William J. Sandborn, Stephen B. Hanauer, Seymour Katz, Michael Safdi, Douglas G. Wolf, Richard D. Baerg, William J. Tremaine, Therese Johnson, Nancy N. Diehl, Alan R. Zinsmeister, Etanercept for active Crohn's disease: a randomized, double-blind, placebo-controlled trial. Gastroenterology. ,vol. 121, pp. 1088- 1094 ,(2001) , 10.1053/GAST.2001.28674