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SHR Neuro Krebs Kardio Lipid Stoffw Microb

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 [OPEN ACCESS]
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Co-Autor*innen der Med Uni Graz
Hauer Almuthe
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Abstract:
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.
Find related publications in this database (using NLM MeSH Indexing)
Adolescent -
Anti-Inflammatory Agents, Non-Steroidal - adverse effects
Anti-Inflammatory Agents, Non-Steroidal - therapeutic use
Antibodies, Monoclonal - adverse effects
Antibodies, Monoclonal - therapeutic use
Biomedical Research -
Biosimilar Pharmaceuticals - adverse effects
Biosimilar Pharmaceuticals - therapeutic use
Child -
Child, Preschool -
Clinical Trials as Topic -
Clinical Trials as Topic -
Gastrointestinal Agents - adverse effects
Gastrointestinal Agents - therapeutic use
Humans -
Inflammatory Bowel Diseases - drug therapy
Needs Assessment -
Pediatrics - methods
Product Surveillance, Postmarketing -
Societies, Medical -

Find related publications in this database (Keywords)
biosimilar
inflammatory bowel disease
infliximab
paediatric
position paper
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