- Reference Number: HEY-971/2018
- Departments: Pharmacy
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What are biological medicines (biologics)?
Biologics are drugs that mimic or block natural chemicals in your body. They are manufactured by the pharmaceutical industry in a complex process which involves producing the molecule and then purifying and cleaning it. Rituximab works by binding to a naturally occurring chemical present on the surface of cells, called an antigen, which then stops an immune reaction from occurring. Biologics are extensively used in the treatment of inflammatory diseases such as rheumatoid arthritis, axial spondyloarthropathy, psoriatic arthritis, psoriasis, Crohn’s disease and ulcerative colitis.
What is a biolsimilar?
The World Health Organization (WHO) has defined a biosimilar as a drug that is similar in terms of quality, safety and efficacy (effectiveness) to the original licensed product. This means that biosimilars (such as Truxima) are allowed to have small structural differences from the original licensed product (Mabthera) but this must not alter how well the drug works, how safe it is, or how the drug reacts with the body’s immune system. The process for manufacturing Mabthera, the original rituximab, has itself altered several times since it was first introduced resulting in a cleaner drug with fewer side effects. Truxima has been assessed against the last versions of Mabthera. Biosimilars are regulated in a similar way to the original licensed product. The European Medicines Agency has approved the use of Truxima as it has been shown to be as safe and as effective as Mabthera.
Do biosimilars work as well?
There have been a number of research studies comparing how well biosimilars work and their safety. There appear to be no differences between the original biologics and the new biosimilars. Over the years, experience with biosimilars of other drugs has been acquired in this hospital and we have no new issues reported. We expect patients switching to a biosimilar to have the same response as if they had stayed on the original biologic. Unfortunately, all drugs may stop being effective at some point in time, but this is no more likely to happen with Truxima than it is with Mabthera.
Are biosimilars safe?
Biosimilars have a similar safety profile to the original biologics. The regulator of new drugs, the European Medicines Agency, has declared biosimilar drugs safe and interchangeable with the original drugs. National Institute for Clinical Excellence and Care (NICE) has also supported this position. You may be aware that the patent for Mabthera has expired and several biosimilars have been approved and are available to patients. The biosimilar drug for rituximab Mabthera used at HEY NHS Hospitals Trust is marketed under the trade name Truxima. Since Truxima offers cost savings and enables us to deliver care more effectively, we aim to gradually switch all patients currently using Mabthera over to Truxima.
Why am I receiving this leaflet?
You may be aware that the patent for Mabthera has expired and several biosimilars have been approved and are available to patients. The biosimilar drug for rituximab Mabthera used at HEY NHS Hospitals Trust is marketed under the trade name Truxima. Since Truxima offers cost savings and enables us to deliver care more effectively, we aim to gradually switch all patients currently using Mabthera over to Truxima.
What does this mean for me?
As Truxima and Mabthera contain the same active product (rituximab), treatment for your medical condition remains unchanged. You will receive Truxima at your next appointment in Medical Day Unit. The appointment will last the same amount of time and the same amount of monitoring will be done by the Nurses.
What happens if I change to a biosimilar and develop side effects?
Please be assured that we would not be offering this alternative medicine unless we were completely confident that it was just as safe and effective as your current medication. When switching to a biosimilar it is not expected that there will be any issues. However if you do develop a side effect, you will be informed of the process which is in place to manage any complications and deal with them promptly