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 Webtool for data capture. We are now open for expressions of interest for IBD teams to participate in a pharmacovigilance non-interventional study into the biosimilar Zessly (infliximab). Please see the link opposite for more information. 

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!

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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.


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