Registry open for expressions of interest on new biosimilar pharmacovigilance study

Jun 26, 2019

The IBD Registry is inviting UK IBD clinical centres to participate in a post-marketing safety study of patients using Zessly (infliximab), a biosimilar available for the treatment of Inflammatory Bowel Disease (IBD). 

This study is facilitated by the Registry on behalf of Sandoz Ltd, the manufacturer of Zessly. The purpose of the study is to track use of and reactions to the biosimilar in a cohort of IBD patients.  Only those clinical teams prescribing Zessly are eligible to participate. 

Dr Fraser Cummings, Clinical Lead at the IBD Registry, said, “Use of biologics has the potential to change the lives of people with IBD, and the advent of biosimilars has widened availability of these new treatments.   

“The Registry’s pharmacovigilance project follows the use of and allows the capture of any possible reactions to these treatments and is important to build further understanding of and confidence in these medications in real world IBD patients.  

“We are pleased to work with Sandoz in this observational safety study following Zessly use in IBD. If your IBD centre is using Zessly, please consider participating – we would be delighted to hear from you.” 

Participating centres will be provided with a simple online WebTool for data capture and all necessary training materials. Study setup and data entry costs will be reimbursed. 

This is an observational study only, so no additional patient tests or monitoring will be required. The expected completion date will be in 2021.   

The IBD Registry would be pleased to hear from you if you are interested in participating in this study.  

Please email [email protected]  for further information. 


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