The future of biosimilar treatments for MS
Biosimilars are highly similar versions of drugs already available. The UK Government and the NHS want to use more of these biosimilar medicines for MS and other conditions. The natalizumab biosimilar, Tyruko, is already used at some treatment centres, particularly in England. We expect ocrelizumab biosimilars to be introduced in the next few years.
What are biosimilars?
A biosimilar drug is a version of a ‘biologic’ drug. Biologic drugs are made using living organisms or cells taken from animals, humans or plants. Biologic disease modifying therapies (DMTs) for MS include natalizumab, ocrelizumab, and ofatumumab.
When a drug company creates a new drug, they give it a brand name and register it under a patent. This means that, for a specific number of years, they are the only company that can make the drug. When the patent on a biologic drug ends, other companies are allowed to make their own biosimilar versions under different brand names. Biosimilars contain the same active ingredient as the original drug.
Biosimilar treatments go through years of development and testing, including drug trials. They are only made available if evidence shows they work in the same way and are just as safe and effective.
Why is the UK Government promoting biosimilars?
Biosimilars are cheaper than original biologic medicines, so they can help save the NHS money. Biologic medicines are some of the most expensive medicines for the NHS. They want to invest the savings in making more treatments available. The UK Government has committed to improving access to new innovative treatments.
Natalizumab biosimilar Tyruko
In 2024, the natalizumab biosimilar Tyruko was used in the NHS for the first time. Since then, some treatment centres have switched people to Tyruko from Tysabri, the original version of this DMT. Other people have started on Tyruko without ever being on Tysabri.
Most people switched from Tysabri to Tyruko without problems, but it didn’t go well for everyone. Some treatment centres didn’t give people enough information about switching treatments ahead of time, nor enough opportunity to ask questions. And some people reported new side effects and changes to their MS. At some hospitals, it was easy for people to go back on Tysabri if they needed to. In other places, it wasn’t.
The Medicines and Healthcare Products Regulatory Agency (MHRA) monitor all treatments and has monitored Tyruko more closely because of these issues. Evidence confirms that Tyruko is not associated with greater risk of harmful reactions or MS getting worse. This is based on the latest safety data.
This doesn’t mean people’s individual experiences weren’t real. It's important that we get a better understanding of why some people had worse experiences than others.
What have we been doing about MS biosimilars?
Since the issues first emerged with the rollout of Tyruko, we’ve kept in close contact with our medical advisers. And NHS England and the medicine regulator, the MHRA. We’ve raised what we’ve heard from people with MS, and called for:
- people starting Tyruko to be involved in decisions about their treatment, with the chance to ask questions
- people experiencing issues to be able to switch back to Tysabri, wherever they live
- research to understand the issues and why they haven’t affected everyone
- early involvement of patient groups ahead of future biosimilar rollouts.
What’s the future for MS biosimilars?
The NHS in England has five drugs lined up for biosimilar switching in the next few years. This includes one for MS, the DMT ocrelizumab (Ocrevus). They’ll develop a national programme for ocrelizumab to plan for the rollout in England. They’ve said they’re committed to engaging with patient groups to develop the programme. We’ll make sure they stick to this.
The health systems in Wales, Scotland and Northern Ireland also support the use of biosimilar medicines. It’s likely that ocrelizumab biosimilar will be introduced in these nations too.
We’re also contributing to a research project on biosimilars called FOCUS-NHS. It’s funded by the National Institute of Health and Care Research (NIHR). The researchers want to understand what happened with the rollout of Tyruko. They’ll speak to people with MS and clinicians and look at clinical data. Then they’ll work with people with MS, charities including us, clinicians and the NHS. They'll work to design better ways to explain and introduce future biosimilars. We’ll keep you up to date with the findings.
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