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

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.

The Registry has established an observational drug safety study programme 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 biosimilars listed opposite.

If your IBD team is using one of the drugs under study 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.

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.

Drugs under study

Idacio (adalimumab)

The Idacio study is OPEN for hospital participation. Please contact pvsupport@ibdregistryorg.uk for enquiries.

This study is to monitor the use of Idacio, an adalimumab biosimilar, produced by Fresenius-Kabi.

Zessly (infliximab)

The Zessly study is OPEN for hospital participation.  Please contact pvsupport@ibdregistryorg.uk for enquiries.

This study is to monitor the use of Zessly, an infliximab biosimilar, produced by Sandoz.

Hyrimoz (adalimumab)

The Hyrimoz study is OPEN for hospital participation. Please contact pvsupport@ibdregistryorg.uk for enquiries.

This study is to monitor the use of Hyrimoz, an adalimumab biosimilar, produced by Sandoz. There are already eight clinical sites who are listed participate in the Hyrimoz study but as commissioning changes have meant drug changes, we are still open to site recruitment.

 

 

For the pharmaceutical industry – enquiries about joining our study programme

If you have a drug in later stage in the development pipeline that may be indicated for market authorisation for treating ulcerative colitis (UC) or Crohn’s disease (CD), and you are looking to run a post-authorisation observational safety study in the UK we have available capacity in our system to undertake further studies.

We are the national Registry for Inflammatory Bowel Disease in the UK, and well positioned with relationships with clinical teams and an infrastructure in use across the UK nations to support effective clinical data collection.

Please contact us at pvsupport@ibdregistry.org.uk to find out more

 

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.

 

IBD Registry Ltd is a not-for-profit company limited by guarantee - Company Number 11197749.
Our Registered Address is 3 St Andrews Place, Regent’s Park, London NW1 4LB. VAT Number 291683766.