The biological medicine adalimumab, often known by the brand name Humira, has been available on the NHS to treat Crohn’s Disease and Ulcerative Colitis for a number of years. In October 2018 the patent expired for adalimumab, allowing new medications with similar active properties to become available, these are known as ‘biosimilars’.
These changes mean that patients currently being treated with adalimumab may be switched to one of the alternative new biosimilars, Amgevita, Hyrimoz, Imraldi, and Hulio. The pen options may operate differently, you can find out more here. Patients who are new to biologics may be asked to consider a biosimilar version of adalimumab when discussing possible treatment options with their IBD team.
This programme of switching is being driven by NHS England, as part of a national programme aimed at making the most of NHS resources. During this time it is important for health professionals to adopt the principles of shared decision making and keep patients fully informed about their treatment options.
Have you already been switched to an adalimumab biosimilar? Are you on adalimumab and switching? Are you new to adalimumab treatment and been put on a biosimilar version? Let us know how the changes have affected you, whether good or bad by emailing firstname.lastname@example.org
What is a biological medicine?
Biological medicines are derived from living organisms which means living cells are used to make large, complex, molecule-like proteins, and other substances produced by the body, that can then be used as medicines. Biologicals were first used to treat people with serious illnesses in the UK over 20 years ago and they have improved life for millions of people worldwide.
What is a ‘biosimilar’ medicine?
It is not possible to make an exact copy of an originator biological medicine, in this case adalimumab; because they are made from living cells there will always be some natural and slight differences between them. Therefore, the new versions are known as biosimilars, which means they are highly similar to the originals, and as safe and effective, but they are not a copy. Biosimilar medicines are often less expensive than the original biological medicine. The adalimumab biosimilars are Amgevita, Hyrimoz, Imraldi, and Hulio.
Patient safety and biosimilars
Biosimilars are thoroughly tested and analysed both in the laboratory and in clinical trials. The authorities which regulate and licence medicines in the UK and Europe are confident that biosimilar medicines are as safe and effective as the originator medicine. To be licensed by the European Medicines Agency, a biosimilar medicine must have shown it has no clinically meaningful differences from the originator biological medicine and to have met regulatory requirements in terms of quality, safety and efficacy compared to the originator medicine (NHS England).
Where the National Institute for Health and Care Excellence (NICE) has recommended the originator biological medicine in its guidance, they have stated that the same guidance will normally apply to a biosimilar version of that medicine.
What does this mean for me?
Anyone switching to a new medicine from adalimumab should involve a conversation between you and your clinical team and should take into account your needs, preferences and values as well as all the available clinical evidence.
In a discussion with your clinical team you can understand your options and agree on the most appropriate medicine. In some cases, it may continue to be the originator biological medicine. It is important to note that there may be differences with the biosimilar, for example in the pen used to inject the medicine and homecare arrangements for delivery. If you have concerns you should raise these with your IBD team.
We understand that switching to a new medicine can be an unsettling time, and therefore it is crucial that you are fully informed about the new biosimilars. To find out more about what the changes mean for you please read the NHS Patient FAQs.
The Department of Health, Social Services and Public Safety (HPSS) in Northern Ireland have yet to indicate when they plan to review the biosimilar for adalimumab, but in line with the rest of the United Kingdom, it is likely the switch will be taking place. We will provide an update to members and supporterss when we have additional information. NHS Scotland will not be reviewing adalimumab specifically, but they encourage biosimilar switching and, as such, switching will be taking place. You can read their prescribing framework here. Read the All-Wales Medicine Strategy Group AWMSG’s position statement on biosimilars (pdf).