Paediatr Drugs. 2022 Jan;24(1):57-62. doi: 10.1007/s40272-021-00486-8. Epub 2021 Dec 16.

Valeria Dipasquale ¹, Massimo Martinelli ², Marina Aloi ³, Salvatore Accomando ⁴, Patrizia Alvisi ⁵, Serena Arrigo ⁶, Claudia Banzato ⁷, Matteo Bramuzzo ⁸, Mara Cananzi ⁹, Mara Corpino ¹⁰, Clelia Di Mari ¹¹, Giovanni Di Nardo ¹², Anna Dilillo ¹³, Natale Dodaro ¹⁴, Enrico Felici ¹⁵, Simona Gatti ¹⁶, Francesco Graziano ¹⁷, Maria Teresa Illiceto ¹⁸, Lorenzo Norsa ¹⁹, Anna Opramolla ²⁰, Maria Pastore ²¹, Paolo Maria Pavanello ²², Erminia Romeo ²³, Luca Scarallo ²⁴, Caterina Strisciuglio ²⁵, Giovanna Zuin ²⁶, Claudio Romano ²⁷

Author information

¹Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi", G. Martino University Hospital, University of Messina, Via Consolare Valeria, 98124, Messina, Italy.

²Department of Translational Medical Science, Section of Pediatrics, University of Naples "Federico II", Naples, Italy.

³Pediatric Gastroenterology Unit, Department of Maternal and Child Health, Sapienza University-Umberto I Hospital, Rome, Italy.

⁴Pediatrics Operative Unit, Promise Department, University of Palermo, Palermo, Italy.

⁵Pediatric Gastroenterology Unit, Maggiore Hospital, Bologna, Italy.

⁶Unit of Pediatric Gastroenterology and Endoscopy, IRCCS "Giannina Gaslini" Children's Hospital, Genoa, Italy.

⁷Pediatric Clinic, Department of Surgical Sciences, Dentistry, Gynecology and Pediatrics, University Hospital of Verona, Verona, Italy.

⁸Institute for Maternal and Child Health, IRCCS "Burlo Garofolo", Trieste, Italy.

⁹Pediatric Gastroenterology, Unit of Digestive Endoscopy, Hepatology and Care of the Child with Liver Transplantation, Department for Women's and Children's Health, University Hospital of Padova, Padua, Italy.

¹⁰Pediatric Gastroenterology Unit, Pediatric Clinic, Microcitemico Hospital, AOB, Cagliari, Italy.

¹¹Pediatric Clinic, V. Buzzi Children's Hospital, University of Milan, Milan, Italy.

¹²Pediatric Gastroenterology and Endoscopy Unit, NESMOS Department, Faculty School of Medicine and Psychology, Sapienza University of Rome, Sant'Andrea University Hospital, Rome, Italy.

¹³Maternal and Child Health Department, Sapienza-University of Rome, Santa Maria Goretti Hospital, Polo Pontino, Latina, Italy.

¹⁴Pediatric Unit, Hospital of Cosenza, Cosenza, Italy.

¹⁵Pediatric and Pediatric Emergency Unit, "U. Bosio, Center for Digestive Diseases, Children's Hospital, AO SS Antonio e Biagio e C. Arrigo, Alessandria, Italy.

¹⁶Department of Pediatrics, G. Salesi Children's Hospital, Ancona, Italy.

¹⁷Pediatric Unit, Villa Sofia Cervello Hospital, Palermo, Italy.

¹⁸Pediatric Gastroenterology and Endoscopic Unit, Department of Pediatrics, Santo Spirito" Hospital, Pescara, Italy.

¹⁹Pediatric Gastroenterology and Transplantation, Papa Giovanni XXIII Hospital, Bergamo, Italy.

²⁰Pediatric Gastroenterology Unit, Regina Margherita Children's Hospital, Turin, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza, University of Turin, Turin, Italy.

²¹Division of Pediatrics, IRCCS-Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy.

²²Department of Pediatrics, Regional Hospital Ca' Foncello, Treviso, Italy.

²³Digestive Surgery and Endoscopy Unit, Bambino Gesù Children's Hospital, Rome, Italy.

²⁴Unit of Gastroenterology and Nutrition, Meyer Children's Hospital, Florence, Italy.

²⁵Department of Woman, Child and General and Specialistic Surgery, Luigi Vanvitelli" University of Campania, Naples, Italy.

²⁶Pediatric Department, University of Milano Bicocca, Fondazione MBBM, San Gerardo Hospital, Monza, Italy.

²⁷Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi", G. Martino University Hospital, University of Messina, Via Consolare Valeria, 98124, Messina, Italy. romanoc@unime.it.

Abstract

Objective: The aim was to assess the awareness and real-life use of biosimilars in inflammatory bowel disease (IBD) among the members of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP).

Methods: An anonymous web survey involving all SIGENP IBD units which can prescribe biosimilars was conducted between July 1st and December 1st, 2020. The questionnaire included 18 questions addressing the most relevant aspects of biosimilars in pediatric IBD, i.e., advantages, disadvantages, costs, traceability, general knowledge, and real-life use. A descriptive analysis of responses was performed.

Results: Responses came from 26 pediatric IBD units in Italy, with representation of the North, the Center, and the South of Italy. The majority of participants (n = 20) had spent > 10 years caring for pediatric IBD patients, and worked in a center which had between 100 and 500 registered pediatric IBD patients (n = 14). Most participants (n = 18) reported they were aware that biosimilars have similar efficacy and safety to those of the originator, and all regarded cost-sparing as the main advantage of biosimilars. Most respondents (n = 20) reported they switch from originator to biosimilar in their everyday clinical practice, mostly during the maintenance phase. Most respondents (n = 20) registered no acute adverse events. Nearly all participants felt totally or very confident in using biosimilars.

Conclusions: A few years after the introduction of the first biosimilar into the market, real-life data coming from the major IBD units in Italy confirm a favorable and confident position on the use of biosimilars in pediatric IBD.