• Reference Number: HEY1492/2024
• Departments: Pharmacy
• Last Updated: 30 June 2024

Introduction

This leaflet offers more information about your medicines for your medical conditions and our plans to switch your treatment over from your original biologic to the new biosimilar that is now available. If you have any further questions or concerns after reading this leaflet, please speak to your consultant or specialist nurses.

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. Biologics work by interrupting the naturally occurring immune reaction in the body.

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 as examples.

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 efficacy (effectiveness) to the original licensed product. This means that biosimilars are allowed to have small structural differences from the original licensed product, 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 the original biologic has itself altered several times since it was first introduced resulting in a cleaner drug with fewer side effects. The new biosimilar has been assessed against the most recent versions of the original biologic.

Biosimilars are regulated in a similar way to the original licensed product. The Medicines Healthcare Products Regulatory Agency (MHRA) of the UK have approved the use of the biosimilar as it has been shown to be as safe and as effective as the original biologic.

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 the new biosimilar than it is with the original biologic.

Are biosimilars safe?

Biosimilars have a similar safety profile to the original biologics. The regulator of new drugs, the Medicines and Healthcare products Regulatory Agency (MHRA), has declared biosimilar drugs safe and interchangeable with the original drugs. The National Institute for Clinical Excellence and Care (NICE) has also supported this position.

Why am I receiving this leaflet?

You may be aware that the patent for your biologic medication has expired and several biosimilars have been approved and are now available to patients. Since these biosimilars offer cost savings and enable us to deliver care more effectively, we aim to gradually switch all patients currently using the original biologic over to the new biosimilar.

What does this mean for me?

As the new biosimilar and the original biologic medication contain the same active product, treatment for your medical condition remains unchanged. You will receive the new biosimilar at the time of your next prescription. For this change no additional monitoring is needed.

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, inform your specialist team and they will deal with it promptly.

Should you require further advice on the issues contained in this leaflet, please do not hesitate to contact your Specialist Nursing Team via your usual contact methods.

General Advice and Consent

Most of your questions should have been answered by this leaflet, but remember that this is only a starting point for discussion with the healthcare team.

Consent to treatment

Before any doctor, nurse or therapist examines or treats you, they must seek your consent or permission. In order to make a decision, you need to have information from health professionals about the treatment or investigation which is being offered to you. You should always ask them more questions if you do not understand or if you want more information.

The information you receive should be about your condition, the alternatives available to you, and whether it carries risks as well as the benefits. What is important is that your consent is genuine or valid. That means:

• you must be able to give your consent
• you must be given enough information to enable you to make a decision
• you must be acting under your own free will and not under the strong influence of another person

Information about you

We collect and use your information to provide you with care and treatment. As part of your care, information about you will be shared between members of a healthcare team, some of whom you may not meet. Your information may also be used to help train staff, to check the quality of our care, to manage and plan the health service, and to help with research. Wherever possible we use anonymous data.

We may pass on relevant information to other health organisations that provide you with care. All information is treated as strictly confidential and is not given to anyone who does not need it. If you have any concerns please ask your doctor, or the person caring for you.

Under the General Data Protection Regulation and the Data Protection Act 2018 we are responsible for maintaining the confidentiality of any information we hold about you. For further information visit the following page: Confidential Information about You.

If you or your carer needs information about your health and wellbeing and about your care and treatment in a different format, such as large print, braille or audio, due to disability, impairment or sensory loss, please advise a member of staff and this can be arranged.