TY - JOUR
T1 - Use of biosimilars in paediatric inflammatory bowel disease
T2 - A position statement of the ESPGHAN paediatric IBD porto group
AU - ESPGHAN Paediatric IBD Porto Group
AU - De Ridder, Lissy
AU - Waterman, Matti
AU - Turner, Dan
AU - Bronsky, Jiri
AU - Hauer, Almuthe C.
AU - Dias, Jorge A.
AU - Strisciuglio, Caterina
AU - Ruemmele, Frank M.
AU - Levine, Arie
AU - Lionetti, Paolo
N1 - Publisher Copyright:
Copyright © 2015 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
PY - 2015/10/1
Y1 - 2015/10/1
N2 - 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.
AB - 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.
KW - Biosimilar
KW - Inflammatory bowel disease
KW - Infliximab
KW - Paediatric
KW - Position paper
UR - http://www.scopus.com/inward/record.url?scp=84942508618&partnerID=8YFLogxK
U2 - 10.1097/MPG.0000000000000903
DO - 10.1097/MPG.0000000000000903
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C2 - 26154031
AN - SCOPUS:84942508618
SN - 0277-2116
VL - 61
SP - 503
EP - 508
JO - Journal of Pediatric Gastroenterology and Nutrition
JF - Journal of Pediatric Gastroenterology and Nutrition
IS - 4
ER -