Use of Biosimilars in Paediatric Inflammatory Bowel Disease: A Position Statement of the ESPGHAN Paediatric IBD Porto Group

Lissy de Ridder; Matti Waterman; Dan Turner; Jiri Bronsky; Almuthe C Hauer; Jorge A Dias; Caterina Strisciuglio; Frank M Ruemmele; Arie Levine; Paolo Lionetti; ESPGHAN Paediatric IBD Porto Group

doi:10.1097/MPG.0000000000000903

Use of Biosimilars in Paediatric Inflammatory Bowel Disease: A Position Statement of the ESPGHAN Paediatric IBD Porto Group

J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):503-8. doi: 10.1097/MPG.0000000000000903.

Authors

Lissy de Ridder¹, Matti Waterman, Dan Turner, Jiri Bronsky, Almuthe C Hauer, Jorge A Dias, Caterina Strisciuglio, Frank M Ruemmele, Arie Levine, Paolo Lionetti; ESPGHAN Paediatric IBD Porto Group

Affiliation

¹ *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.

PMID: 26154031
DOI: 10.1097/MPG.0000000000000903

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.

Publication types

Practice Guideline

MeSH terms

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
Europe
Gastrointestinal Agents / adverse effects
Gastrointestinal Agents / therapeutic use*
Humans
Inflammatory Bowel Diseases / drug therapy*
Needs Assessment
Pediatrics / methods
Product Surveillance, Postmarketing
Societies, Medical

Substances

Anti-Inflammatory Agents, Non-Steroidal
Antibodies, Monoclonal
Biosimilar Pharmaceuticals
Gastrointestinal Agents