Biosimilar safety monitoring
The introduction of biological treatments has made a significant difference in the lives of many IBD patients. The advent of multiple biosimilars (generic medicines that are biologically similar to the originator) increases the affordability and so availability of these life-changing treatments.
Dr Fraser Cummings, Clinical Lead for the Registry, talks here about the differences between biosimilars and originator biological agents (video courtesy of NIHR) see also Focus on Biosimilars
Safety studies – open for expressions of interest from IBD teams for Zessly (infliximab)
A primary aim of the IBD Registry is to help improve the quality of life for people with IBD, by using our UK-wide reach to collect and analyse relevant data. The recent introduction of biosimilar medicines has placed the Registry in a key position to facilitate the collection of crucial, on-going safety data as these treatments become more widely used.
We are pleased to announce that the Registry will soon be facilitating a number of safety studies using our
Our first study is to monitor the use of Hyrimoz, an adalimumab biosimilar, produced by Sandoz. There are already ten clinical sites who are negotiating to participate in the Hyrimoz study. The IBD Registry will receive set-up funding to support the data collection and NHS Trusts will receive funding for participating. The study is completely observational, and patients will be asked to consent to their data being used in an anonymised form.
How can sites participate?
- Zessly (infliximab) – click HERE for more information and next steps.
If your IBD team is using Zessly or Hyrimoz please get in touch. The wider the data collection, the more closely it reflects real-world effects, so we encourage you to work with us to gather the evidence.
We will be initiating a number of similar studies shortly so watch this space!
Independent and Transparent
The IBD Registry is an independent organisation with no influence on medical prescribing. We will only work with companies that abide by the ABPI Code of Practice for the Pharmaceutical Industry, which covers the promotion of medicines for prescribing to health professionals and other relevant decision makers.
NEW: IBD Registry, patient consent and the National data opt-out - FINAL (PDF 150KB)
|IBD Registry Patient information leaflet – April 2019||Download here|
|IBD Registry Large Font/Accessible Patient information leaflet – April 2019||Download here|
|IBD Registry Adult consent form – May 2018||Download here|
|IBD Registry Paediatric consent form – May 2018||Download here|
|IBD Registry A4 poster - May 2018||Download here|
|IBD Registry patient consent guidance for hospitals (England and Wales) - August 2017||Download here|
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