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

Biologic therapies have changed the outcome of both adult and paediatric patients with Inflammatory Bowel Disease (IBD). In September 2013, the first biosimilar of infliximab was introduced into the pharmaceutical market. In 2015, a first position paper on the use of biosimilars in paediatric IBD was published by the ESPGHAN IBD Porto group. Since then, more data have accumulated for both adults and children demonstrating biosimilars are an effective and safe alternative to the originator. In this updated position statement we summarize current evidence and provide joint consensus statements regarding the recommended practice of biosimilar use in children with IBD. Address correspondence and reprint requests to Lissy de Ridder, MD, PhD, Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, The Netherlands (e-mail: l.deridder@erasmusmc.nl). Received 7 June, 2018 Accepted 15 August, 2018 Conflicts of interests Ridder, L de – Last 3 years received consultation fee, research grant, or honorarium from ZonMw (national health institute), Janssen, Pfizer, Mundipharma, Shire and Abbvie. Assa, A- Last 3 years received consultation fee, research grant, or honorarium from Abbvie, Janssen and Rafa pharmaceuticals. Bronsky J - Last 3 years received consultation fee and honoraria from AbbVie and MSD. Russell, RK - Has received speaker's fees, travel support, and participated in medical board meetings with Abbvie, Janssen, Shire, Celltrion, NAPP and Nestle. Hauer AC - Last 3 years received consultation fee and honoraria from AbbVie, MSD, Janssen and Nutricia. Lionetti, P - Last 3 years received consultation fee and honoraria from Abbvie, Pfizer and Nutricia. Veres G - Last 3 years received consultation fee from AbbVie, Nutricia, and Nestle. Sladek M - has received consultant fee, speakers fee, travel support, and honoraria from AbbVie, Astellas, Egis, Ferring, Mundipharma, Nestle, Nutricia. Winter H - Last 3 years received consultant fee, royalties, speakers fee, travel support, honoraria and participated in advisory boards for Janssen Pharma, Nutricia, Nestle Nutrition, Abbvie, Shire, Pediatric IBD Foundation, Women's Wellness, QOL, Autism Research Foundation, UpToDate. Vulto, A – Has received consultation fees, speakers fees, and participated in advisory boards for AbbVie, Biogen Idec Ltd, Pfizer / Hospira Inc, Novartis / Sandoz Ltd., Samsung Bioepis, Amgen Inc; Bristol Meyers Squibb, F. Hoffmann-La Roche Ltd, Eli Lilly, Febelgen, Medicines for Europe AISBL, Mundipharma, Hexal / Sandoz Ltd., Biogen Idec Ltd, Boehringer-Ingelheim. Dias, J – Has received speakers' fee from Abbvie, Danone, Nestlé. Partcipated at Advisory board of Celgene, Danone and Falk. © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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