DOP078 Are IBD specialists aware of biosimilar monoclonal antibodies? Results from a survey among ECCO members

Abstract

Background: Monoclonal antibodies (mAb) are effective therapies in immune mediated inflammatory diseases (IMID), including inflammatory bowel disease (IBD). High cost for healthcare systems is a main limitation for the use of mAb in these conditions. Recently, 2 infliximab biosimilar mAb have been approved by regulatory agencies for all IMID indications, based on a randomized controlled trial (RCT) in rheumatoid arthritis, showing equivalence to the original mAb. No data are available for other indications. Current knowledge on the efficacy, safety and use of biosimilar mAb among gastroenterologists is unknown. We developed a web survey aimed at IBD specialists to evaluate their awareness of biosimilar mAb and readiness to use these therapies. Methods: A 15-question anonymous web survey was conducted with the logistic support of ECCO. Randomly selected ECCO members were invited by to participate. Information on gender, job position, country and mAb experience were collected. Results: Of 272 responders, 69% worked in a University Hospital, 33% as consultants, 88% autonomously prescribe mAb for >2 years. Two thirds were aware that biosimilar mAbs are not the same molecules as their originators (69%) and agreed that biosimilars should carry distinct International Nonproprietary Names. Most responders regarded cost-sparing (89%) as the main advantage of biosimilars, immunogenicity (69%) as their main concern, and estimated that post-marketing pharmacovigilance, well-designed RCT and further study of risk profile were needed (54%, 66%, 63% resp.). For prescription, 85% disagreed with automatic replacement of the originator with a biosimilar by a pharmacist, although 18% would support substitution for new prescriptions. Most clinicians thought that medical societies should promote information about biosimilars (median 66%), collaborate with health institutions to develop rules (78%) and guidelines (57%) on the use of biosimilars, and create multispecialty safety registries (80%). Most responders (73%) thought that patient organizations should be involved in these processes. Only 6% of responders thought that the originator and biosimilar mAb were interchangeable, although 28% would replace scheduled originator therapy with a biosimilar. If equivalence was shown by RCTs in IBD, 49% of responders thought a biosimilar should be first choice because of costs, although 27% thought the savings would be marginal. Most (63%) felt little or not confident in the use of biosimilar mAb. Conclusions: IBD specialists are generally informed on biosimilars, but think they are not interchangeable with the originator, unless strong evidence is shown about similarity for each indication. Most clinicians do not feel confident on the use of biosimilars in clinical practice.