After its patent expires on 16 October 2018, new medications with similar active properties - or “biosimilar" versions - will be available. This may mean that patients currently being treated by adalimumab will be invited to ‘switch’ to (be prescribed) one of the alternative new biosimilars.
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.
This is not the first time biosimilars have been introduced to treat people with IBD. A similar switch took place in 2016, with the introduction of Inflectra and Remsima which are biosimilars for infliximab, the original product being Remicade.
We welcome increased availability of effective treatment options for patients and understand the importance of the wise and careful use of NHS resources. Crohn’s and Colitis UK has been working in the field of biosimilars to provide patient information and support since 2014 and is familiar with the evidence to date which reinforces the fact that biosimilars are as safe and effective as the reference products. The introduction of biosimilars for adalimumab brings potential opportunities for both patients and the NHS. However, it is vital that patients are fully informed about all the treatment options available to them and commissioners and health professionals adopt the principles of shared decision making. At a time when services are thinking about new contracts, we would also hope that patients’ views are proactively sought and that things that matter to patients, including excipients, device and homecare packages, are given due consideration.
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.
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?
Any 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 and the Scottish Medical Consortium (SMC) in Scotland have yet to indicate when they plan to review the biosimilar for adalimumab, but when they do we will communicate this fact to members and supporters. Read the All-Wales Medicine Strategy Group AWMSG’s position statement on biosimilars (pdf).