Journal of Pediatric Gastroenterology and Nutrition · 2015 · 39 citations · 23 references
MedicinePediatricsPharmacologyPediatric ImmunologyPediatric RheumatologyRheumatologyBiosimilar RegulationInflammatory Bowel DiseaseNew Drug ApplicationsPediatric Clinical TrialsPost-market SurveillanceAccess To BiosimilarsBiologic Drug CostsBiosimilar UseInflammatory Bowel Disease TherapyMarket Access For BiosimilarsPostmarketing Adverse Event SurveillancePostmarketing Safety SurveillanceRheumatologic Disease Management
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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Dae‐Hyun Yoo, Paweł Hrycaj, Pedro C. Miranda et al. · Annals of the Rheumatic Diseases · 2013 · 653 citations · Full text