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de Ridder, L; Waterman, M; Turner, D; Bronsky, J; Hauer, AC; Dias, JA; Strisciuglio, C; Ruemmele, FM; Levine, A; Lionetti, P; ESPGHAN Paediatric IBD Porto Group.
Use of Biosimilars in Paediatric Inflammatory Bowel Disease: A Position Statement of the ESPGHAN Paediatric IBD Porto Group.
J Pediatr Gastroenterol Nutr. 2015; 61(4):503-508
Doi: 10.1097/MPG.0000000000000903
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- Co-Autor*innen der Med Uni Graz
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Hauer Almuthe
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- Abstract:
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Because the patents for biopharmaceutical monoclonal antibodies have or soon will expire, biosimilars are coming to the market. This will most likely lead to decreased drug costs and so easier access to these expensive agents. Extrapolation, however, of the limited available clinical data from adults with rheumatologic diseases to children with inflammatory bowel disease (IBD) should be done with caution and needs some considerations.Postmarketing surveillance programs for efficacy, safety, and immunogenicity should become mandatory in children with IBD using biosimilars, as for all biological drugs.
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Adolescent -
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Anti-Inflammatory Agents, Non-Steroidal - adverse effects
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Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
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Antibodies, Monoclonal - adverse effects
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Antibodies, Monoclonal - therapeutic use
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Biomedical Research -
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Biosimilar Pharmaceuticals - adverse effects
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Biosimilar Pharmaceuticals - therapeutic use
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Child -
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Child, Preschool -
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Clinical Trials as Topic -
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Clinical Trials as Topic -
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Gastrointestinal Agents - adverse effects
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Gastrointestinal Agents - therapeutic use
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Humans -
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Inflammatory Bowel Diseases - drug therapy
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Needs Assessment -
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Pediatrics - methods
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Product Surveillance, Postmarketing -
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Societies, Medical -
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biosimilar
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inflammatory bowel disease
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infliximab
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paediatric
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position paper