title: Use of Biosimilars in Paediatric Inflammatory Bowel Disease: A Position Statement of the ESPGHAN Paediatric IBD Porto Group.
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.
authors.affiliation: *Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands †Department of Gastroenterology, Inflammatory Bowel Diseases Service, Rambam Health Care Campus, Haifa ‡Institute of Paediatric Gastroenterology, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel §Department of Paediatrics, University Hospital Motol, Prague, Czech Republic ||Department of Paediatrics and Adolescence Medicine, GPGE Educational Center of Paediatric Gastroenterology, Medical University of Graz, Austria ¶Pediatric Gastroeneterology Department, Hospital Sao Joa, Porto, Portugal #Department of Woman, Child, and General and Specialized Surgery, Second University of Naples, Naples, Italy **Université Paris Descartes-Sorbonne Paris Cité, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants Malades, Service de Gastroentérologie Pédiatrique, INSERM U1163, Institute IMAGINE, Paris, France ††Paediatric Gastroenterology Unit, Wolfson Medical Center, Tel Aviv University, Israel ‡‡Department of Neuroscience, Psychology, Pharmacology and Child's Health, University of Florence, Meyer Hospital, Florence, Italy.
authors.forename: Lissy
authors.initials: L
authors.lastname: de Ridder
authors.forename: Matti
authors.initials: M
authors.lastname: Waterman
authors.forename: Dan
authors.initials: D
authors.lastname: Turner
authors.forename: Jiri
authors.initials: J
authors.lastname: Bronsky
authors.forename: Almuthe C
authors.initials: AC
authors.lastname: Hauer
authors.forename: Jorge A
authors.initials: JA
authors.lastname: Dias
authors.forename: Caterina
authors.initials: C
authors.lastname: Strisciuglio
authors.forename: Frank M
authors.initials: FM
authors.lastname: Ruemmele
authors.forename: Arie
authors.initials: A
authors.lastname: Levine
authors.forename: Paolo
authors.initials: P
authors.lastname: Lionetti
mesh_terms: D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D035843:Biomedical Research; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D005060:Europe; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D020380:Needs Assessment; D010372:Pediatrics / Q000379:methods; D011358:Product Surveillance, Postmarketing; D012955:Societies, Medical
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; D005765:Gastrointestinal Agents