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 and the Registry

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. Our first study will monitor the use of Hyrimoz, an adalimumab biosimilar, produced by Sandoz. 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?

Biosimilar treatments we are monitoring:

  • Hyrimoz (adalimumab) – click HERE for more information
  • Zessly (infliximab) – coming soon

If your IBD service is using one of these biosimilars, please get in touch to participate in these important studies. 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.


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