- Reference Number: HEY-893/2017
- Departments: Pharmacy
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This leaflet offers more information about your medicines for your medical conditions and our plans to switch your treatment over from Remicade to Remsima. If you have any further questions or concerns after reading this leaflet, please speak to your doctor or the nurses at Medical Day Unit (MDU) or Immunomodulator Infusion Centre (IMIC).
Why am I receiving this leaflet?
The patent for Remicade has expired and several biosimilars have been approved and are available to patients. The biosimilar drug for infliximab Remicade used at this hospital is marketed under the trade name Remsima. Since Remsima offers cost savings and enables us to deliver care more effectively, we aim to gradually switch all patients currently using Remicade over to Remsima.
What does this mean for me?
As Remsima and Remicade contain the same active product (infliximab), treatment for your medical condition remains unchanged. You will receive Remsima from your next infusion day. No additional monitoring is need.
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. Infliximab works by stopping the naturally occurring chemical, called TNF (tumor necrosis factor), from binding to cells that cause inflammation.
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 biosimilar?
The World Health Organization (WHO) has defined a biosimilar as a drug that is similar in terms of quality, safety and effectiveness to the original licensed product. This means that biosimilars (such as Remsima) are allowed to have small structural differences from the original licensed product (Remicade) 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 Remicade, the original infliximab, has itself altered more than thirty times since it was first introduced resulting in a cleaner drug with fewer side effects. Remsima has been assessed against the last versions of Remicade.
Biosimilars are regulated in a similar way to the original licensed product. The European Medicines Agency has approved the use of Remsima as it has been shown to be as safe and as effective as Remicade.
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 Remsima than it is with Remicade.
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.
What happens if I change to a biosimilar but I have 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 dealt with promptly. If you wish to know more about side effects, please discuss with the nursing team.
If you have any further questions, please contact the
Inflammatory Bowel Disease (IBD) Nursing Team, (01482) 608982/676410
Rheumatology Nursing Team Advice Line (01482) 608779; Mon 11am – 3pm, Tue 8am – 10am, Wed 1pm – 4pm and Fri 9am – 11am
Dermatology Nursing Team, (01482) 622484/624093
Additional services and information
- NHS Choices: NHS Choices provides online information and guidance on all aspects of health and healthcare, to help you make decisions about your health.
- Web: www.nhs.uk
- NHS 111: You can call 111 when you need medical help fast but it’s not a 999 emergency. NHS 111 is available 24 hours a day, 365 days a year. Calls are free from landlines and mobile phone
This leaflet was produced by the Pharmacy Department, Hull University Teaching Hospitals NHS Trust and will be reviewed in June 2020.