P545 Antigenic response to CT-P13 and remicade in inflammatory bowel disease patients shows similar epitope recognition

Editorial: antigenic response to CT‐P13 and infliximab originator in IBD shows similar epitope recognition—evidence from basic science supports safe switching to biosimilars

“…Previous trials in patients with RA and IBD showed that antibodies to Remicade (Jansen Biotech, USA), the infliximab originator, similarly recognised and cross‐reacted with infliximab biosimilars. This study of Goncalves et al is the first to compare specific antigenic epitopes between CT‐P13 and Remicade, and to identify antibody‐binding sites on different versions of infliximab with poly‐ and monoclonal sera . Their results seem to confirm similar immunodominant epitopes and immunogenic potential of the two agents.…”

“…Their results seem to confirm similar immunodominant epitopes and immunogenic potential of the two agents. In line with other recent reports, ADA‐positive sera of CT‐P13‐sensitised IBD patients were cross‐reactive with five different batches of both Remicade and CT‐P13, and this regardless whether or not patients were pre‐exposed to Remicade …”

Outcomes of Patients With Inflammatory Bowel Diseases Switched From Maintenance Therapy With a Biosimilar to Remicade

“…Recent studies reported that antibodies to IFX in patients treated with either the originator biologic or the biosimilar present similar epitope recognition and reactivity 581 582 583 584 585 586 587 588 589 590 591 592 593 594 595 596 597 598 599 600 601 602 603 604 605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 620 621 622 623 624 625 626 627 628 629 630 631 632 633 634 635 636 637 638 toward biosimilars CT-P13 and also SB2 as well as that tested TDM assays can equivalently measure either the reference IFX drug or any of the approved biosimilars CT-P13 or SB2. [29][30][31][32] Continuous robust capture of pharmacovigilance data with long-term follow-ups and multiple switching sequences are needed to support decision making around interchangeability of biosimilars.…”

Editorial: antigenic response to CT‐P13 and infliximab originator in IBD shows similar epitope recognition—evidence from basic science supports safe switching to biosimilars. Authors’ reply

“…We thank Peyrin‐Biroulet and colleagues, Mariaangela Alloca and Lieven Pouillan, for their interest in our work . We agree with them that post‐marketing pharmacovigilance, together with prospective and retrospective observational studies, will remain important to detect rare potential immunogenic events.…”

“…The authors’ declarations of personal and financial interests are unchanged from those in the original article …”