Copyright 2015 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited. Use of Biosimilars in Paediatric Inflammatory Bowel Disease: A Position Statement of the ESPGHAN Paediatric IBD Porto Group  Lissy de Ridder, y Matti Waterman, z Dan Turner, § Jiri Bronsky, jj Almuthe C. Hauer, ô Jorge A. Dias, # Caterina Strisciuglio,  Frank M. Ruemmele, yy Arie Levine, and zz Paolo Lionetti, on Behalf 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. Post- marketing surveillance programs for efficacy, safety, and immunogenicity should become mandatory in children with IBD using biosimilars, as for all biological drugs. Key Words: biosimilar, inflammatory bowel disease, infliximab, paediatric, position paper (JPGN 2015;61: 503–508) B iological medicines are complex protein-based compounds derived from a biological source as defined by the European Medicines Agency (EMA) (1). These proteins have a much larger molecular structure than the standard pharmacological prep- arations. When such small molecule drugs’ patents expire, generic products are introduced. Because of both their structure and bio- logical activity, however, the counterpart of generics in terms of biologicals is called biosimilars (1). The World Health Organization has defined these as ‘‘a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product’’ (2). Because of the structure of the bio- logical molecules and trade secrets of the companies producing the original products, the new versions are very similar but not exactly identical to the originator drug. These products do not need to go through the same complex licensing process for approval as new small molecules, thereby bringing down their cost (Fig. 1) (3). Biosimilars may also be cheaper because it is possible to produce molecules which are almost identical to the original product through alternative methods. The pricing difference, however, may be less pronounced than when producing generics because of the complex manufacturing process which large-molecule biosimilars require (4,5). Overall, a lower price should result, allowing wider access to this expensive class of medications. Agencies including the US Food and Drug Administration (FDA) and EMA decided that for biosimilars, documentation of efficacy is not needed for all of the indications of the original molecule. Extrapolation may be acceptable provided that the phar- macokinetic (PK) and pharmacodynamic properties have been demonstrated in studies of all levels (in vitro, animal models, and clinical trials) in some of the indications, (3). Because biosimilars have now come to the market in some countries, an overview is given on behalf of the paediatric inflam- matory bowel disease (IBD) Porto group on the use of biosimilars in paediatric IBD (PIBD). The PIBD Porto group is a group of PIBD experts from European Society for Paediatric Gastroenterology, Hepatology, and Nutrition whose goals are to generate collaborative Received May 11, 2015; accepted July 2, 2015. From the  Paediatric Gastroenterology, Erasmus Medical Center/Sophia Children’s Hospital, Rotterdam, The Netherlands, the y Department of Gastroenterology, Inflammatory Bowel Diseases Service, Rambam Health Care Campus, Haifa, the z Institute of Paediatric Gastroenterol- ogy, Shaare Zedek Medical Center, The Hebrew University of Jerusa- lem, Israel, the § Department of Paediatrics, University Hospital Motol, Prague, Czech Republic, the jj Department of Paediatrics and Adoles- cence Medicine, GPGE Educational Center of Paediatric Gastroenter- ology, Medical University of Graz, Austria, the ô Pediatric Gastroeneterology Department, Hospital Sao Joa, Porto, Portugal, the # Department of Woman, Child, and General and Specialized Surgery, Second University of Naples, Naples, Italy, the  Universite ´ Paris Descartes—Sorbonne Paris Cite ´, Assistance Publique—Ho ˆpitaux de Paris, Ho ˆpital Necker Enfants Malades, Service de Gastroente ´rologie Pe ´diatrique, INSERM U1163, Institute IMAGINE, Paris, France, the yy Paediatric Gastroenterology Unit, Wolfson Medical Center, Tel Aviv University, Israel, and the zz Department of Neuroscience, Psychology, Pharmacology and Child’s Health, University of Florence, Meyer Hos- pital, Florence, Italy. Address correspondence and reprint requests to Lissy de Ridder, MD, PhD, Paediatric Gastroenterology, Erasmus Medical Center/Sophia Chil- dren’s Hospital, Rotterdam, The Netherlands (e-mail: l.deridder@ erasmusmc.nl). This article has been developed as a Journal CME Activity by NASP- GHAN. Visit http://www.naspghan.org/content/59/en/Continuing- Medical-Education-CME to view instructions, documentation, and the complete necessary steps to receive CME credit for reading this article. All of the authors have contributed equally to this study. In the last 3 years, consultation fees, research grants, or honoraria were received by L.R. from Shire, Merck, Janssen Biologics, AbbVie, and Hospira; by M.W. from Janssen Biologics, AbbVie, and Takeda; by D.T. from Merck Sharpe & Dohme (MSD), Janssen Biologics, Pfizer, The Hospital for Sick Children, Ferring, AbbVie, and Abbott; by J.B. from MSD, AbbVie, Abbott, Ferring, Nestle ´, Nutricia, and Biocodex; by A.C.H. from MSD and Janssen; by F.M.R. from Janssen, AbbVie, Falk, MSD, Shire, Nestle ´, Danone, and Celgene; and by A.L. from Janssen, AbbVie, Falk, and Nestle ´. The other authors report no conflicts of interest. Copyright # 2015 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition DOI: 10.1097/MPG.0000000000000903 SOCIETY CLINICAL REPORT JPGN  Volume 61, Number 4, October 2015 503