Real-Life Use of Biosimilars in Pediatric Inflammatory Bowel Disease: A Nation-Wide Web Survey on Behalf of the SIGENP IBD Working Group

Abstract

ObjectiveThe 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.

Biosimilars in Pediatric Inflammatory Bowel Diseases: A Systematic Review and Real Life-Based Evidence

“…Biosimilars offer a more advantageous costing and reimbursement strategy, with price cuts ranging from 25 to 70% in Europe when compared to originator products ( Brodszky et al, 2016 ). More than 90% of respondents in the previously cited Italian survey believed biosimilars to be cost-effective, with cost savings being the most important benefit of using biosimilars ( Dipasquale et al, 2021 ). If the cost savings from the use of biosimilars were used to fund more biological treatments, several more IBD patients could be treated.…”

“…CT-P13 can be regarded as a good alternative to the originator for induction and maintenance of remission in children with IBD, according to the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) Pediatric IBD Porto Group ( de Ridder et al, 2015 ; de Ridder et al, 2019 ). A recent nationwide web survey conducted in Italy showed that most pediatric IBD experts have good knowledge about biosimilars, with awareness of similar efficacy and safety in comparison to the originator ( Dipasquale et al, 2021 ).…”

Biosimilars in Pediatric IBD: Updated Considerations for Disease Management

“…57,58 A more recent web survey revealed that pediatric IBD experts in Italy have a good level of knowledge on biosimilar use advantages, disadvantages, costs, and traceability. 59 The increasing confidence in biosimilar use may be linked to the growing post-marketing studies and the dissemination of real-world data. Patient education is also an important aspect of the acceptance of biosimilar treatment.…”