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.
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.
Pharmacovigilance case study with IBD Nurse Specialist Becky George
Pharmacovigilance (PV) plays a crucial role in monitoring and ensuring the safety of pharmaceutical products. This case study, from IBD Nurse Specialist Becky, explores the implementation of a pharmacovigilance study for Zessly, a biosimilar used in the treatment of various inflammatory conditions including IBD.
How is the income received from involvement in the Zessly study used at your hospital?
The Zessly income is used to fund support access to conferences and study opportunities and will enable a fixed term member of staff to continue submitting data in the future.
How much time was spent on the study?
I spent roughly 4 hours a week checking and submitting data for Zessly, but that included catching up with biologic reviews etc.
How did you manage Zessly PV specific work?
I asked for all clinical correspondence to be copied to me from clinics and I used that information to populate the Registry data generally and specifically for Zessly. We were also notified of admissions, so I could capture Serious Adverse Events (SAEs) that way when I knew about them. I would say once a week I spent at least 4 hours specifically on Zessly. Patients on the Zessly study also emailed our generic email if they had any issues so I picked up that way too.
How was your experience with learning the process for Zessly?
The process was fairly clear and the protocol concise, I initially had a few questions around entering data, but it was not difficult. I had already been a research nurse so consenting patients etc. was well known to me.
Did the PV study provide any useful insights to your team?
Yes, we had a much clearer understanding of the SAEs the patients displayed. We were able to look into several patients in detail who had unusual reactions/side effects. More broadly, the number of SAEs surprised us as we had always considered our patients rarely had any issues.