BSG Guidance on the Use of Biosimilar Infliximab CT-P13 in IBD
Introduction: Dr AB Hawthorne, Chair BSG IBD Section Committee
The infliximab biosimilar CT-P13 (Remsima or Inflectra) received marketing authorisation in June 2013.The drug is now widely used in the treatment of inflammatory bowel disease. There is sufficient data from observational studies to show that safety and clinical efficacy of CT-P13 are comparable to the originator drug, with similar immunogenicity.
- Infliximab must be prescribed by brand name (ie Remicade, Remsima or Inflectra) and not by International Non-proprietary Name (INN).
- For patients starting infliximab: Remicade, Remsima or Inflectra can be prescribed, taking into account the evidence showing similar clinical effectiveness. There is evidence that monitoring of patients, including measurement of drug and anti-drug antibody levels, is no different for the biosimilar drugs compared to Remicade. The choice of preparation should take into account the cost of the drug and its administration.
- There is sufficient evidence to recommend that patients who are in a stable clinical response or remission on Remicade therapy can be switched to Remsima or Inflectra at the same dose and dose interval. This should be done after discussion with individual patients, with explanation of the reason for switching (which is usually on the grounds of benefit to the overall service by reduction in costs of the drug and its administration).
- Automatic substitution, (dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber), is not appropriate.
- Pharmacovigilance is essential for any new biological medicine, and patients prescribed Remsima or Inflectra should be followed for safety, in a registry such as the UK National IBD Registry.
This document replaces the previous BSG guidance on Biosimilar drugs - IBD Section Statement on Biosimilar drugs (2014) (View here)
- Download guidance [ 330 kb ]
Fourth report of the biological therapy element of the UK IBD audit
Latest UK IBD audit report shows further improvement for patients following treatment with biological therapies
The UK inflammatory bowel disease (IBD) clinical audit report reveals today that the majority of patients (80% adult and 77% paediatric) with Crohn's disease saw an improvement following biological therapies
This is the fourth report of the biological therapy element of the UK IBD audit. The purpose of this audit is to measure the efficacy, safety and appropriate use of the biological therapies infliximab and adalimumab, also known as anti-TNFα drugs, in patients with IBD in the UK. The audit also aims to capture patients’ views on their quality of life at intervals during their treatment.
The data presented in the reports demonstrate that biological therapies for IBD are effective and relatively safe treatments. Patterns of use are changing, with earlier use in patients with less severe disease. It is likely that this reflects more appropriate prescribing as physicians become more familiar with these drugs.
National and executive summary versions of both adult and paediatric reports are available on the Royal College of Physicians' website:
Biosimilar Medicines: all you need to know
Professor Chris Probert, Chair BSG IBD Committee
The announcement by NICE that anti-TNFs may be used, within licence, for patients with ulcerative colitis has coincided with the launch of two biosimilar infliximabs in the UK.
We (BSG) are arranging an educational meeting in conjunction with representatives from the Association of the British Pharmaceutical Industry Biological Medicines Access Group (ABPI BMAG), Hospira and Napp. Our goal is to deliver an educational event with talks from all interested parties as well as from MHRA and NICE. The meetings are on 9th (London) and 16th (Manchester) June and commence at 14:00.
- Download the agenda [ 619 kb ]
- Download the invitation letter [ 619 kb ]
- Download the reply form [ 619 kb ]
IBD Registry Preliminary Data Presented
At BSG 2014, Clinical Lead, Dr Fraser Cummings presented the first data on over 4000 patients from the UK IBD Registry. This presentation gives an idea of the trends that can be observed using Registry data, such as patients' smoking status or medication. One important development is the linkage with Hospital Episode Statistics (HES) data, which shows healthcare utilisation, e.g. the number of outpatient appointments and A&E admissions each year.
Early Adopters' Lead, Dr Matthew Johnson provided practical advice on using the Registry Patient Management System (PMS) to support patient care, and explained how he and his team at Luton and Dunstable University Hospital have successfully used the system to fund an additional IBD specialist nurse.
We also launched our new Registry Information Pack, a step-by-step guide to joining the IBD Registry, including information for clinical teams, IT and Caldicott Guardians as well as an example business case, PMS screen shots and letters.
Setting the Registry within the broader context of raising standards in IBD, the panel also included Professor Mark Baker, Director of the NICE Centre for Clinical Practice, Dr Ian Arnott, Clinical Lead of the UK IBD Audit and David Barker, Chief Executive of Crohn's and Colitis UK and Chair of IBD Standards and Dr Stuart Bloom, Chair of IBD Registry.
Summing up the meeting, Crohn's and Colitis UK Chief Executive, David Barker commented: "The work of the IBD Standards, Audit and Registry are really critical in terms of driving up standards of care for patients."
IBD Nixon Twin and Multiplex Registry
Page 3 of 4