For a biologic medicine, different brands are slightly different from each other. This is because biologics are complex medicines made by living cells, so it is not possible to make an exact copy. These slightly different brands are called biosimilars. They are very similar to the original biologic medicine.
Biosimilars are fully tested to make sure they are as safe and effective as the original brand.
What biosimilars are available for ustekinumab?
There are currently four ustekinumab biosimilars available. These are:
- Pyzchiva
- Steqeyma
- Uzpruvo,
- Wenzela
Will everyone taking Stelara be switched?
Ustekinumab biosimilars are not currently approved for use in Ulcerative Colitis. So only those with Crohn’s are likely to be considered for switching. But this may change.
Will it work as well as Stelara?
Yes, all biosimilars are fully tested to show they work just as well and are just as safe as the original biologic.
Are biosimilars given the same way as Stelara?
The first dose of ustekinumab is usually given through a drip into a vein. This is called an intravenous infusion. Pyzchiva, Steqeyma and Wenzela are available as an intravenous infusion for the first dose. But Uzpruvo is not, so another ustekinumab product will be given as the first dose.
After the first dose, you have ustekinumab as an injection under the skin. This is called a subcutaneous injection. The Stelara injection comes as a pre-filled syringe and as a pre-filled pen. You can inject these yourself at home. The biosimilars come as pre-filled syringes, but not as pre-filled pens. It is unlikely that people using Stelara pre-filled pens will be switched to a biosimilar pre-filled syringe. The biosimilars will probably be available as pre-filled pens in the future.
The biosimilar device may look different from Stelara. But your doctor, nurse, or a member of your homecare team should show you how to use it.
You will take the biosimilar injections every 8 or 12 weeks, the same as Stelara.
Are the storage instructions the same?
Yes, you need to keep the biosimilar pre-filled syringes in a fridge. Or, if you need to, you can keep them out of the fridge at room temperature for up to 30 days.
How can I report any problems?
If you have any problems, including any side effects, after switching brands, tell your IBD team. You can also report any side effects through the Yellow Card scheme online or by downloading the MHRA Yellow Card app (yellowcard.mhra.gov.uk).
How will I know if I am going to be switched to a biosimilar?
Your local NHS trust will decide who will be switched over. People will usually be contacted by letter, phone or email to inform them about the options to switch. We are aware that letters have already gone out from some trusts.
Do I have to switch?
We understand that some people might feel uneasy about switching.
If your local trust considers that a biosimilar is right for you, then they will contact you, and your next dose will be switched to a biosimilar. In most cases this will happen without any further discussion.
If you have any concerns, contact your IBD team.
Can I switch back if it does not work as well?
Biosimilars have the same efficacy as the original biologic. This means that ustekinumab biosimilars should work as well as Stelara.
Sometimes, ustekinumab stops working so well over time. But this would happen with the biosimilars or Stelara. In this case, your IBD team may want to try a different medicine rather than switch back to Stelara.
I get Stelara delivered to my home. Will it be the same with the new biosimilar?
Ustekinumab for injection at home will usually be delivered to you directly by a homecare medicines provider. Different homecare companies may be used for each medicine. If the switch to a biosimilar means that your homecare provide will also be changing, you should be sent the contact details of the new provider. There should not be a disruption or delay in supply. If you have any issues or problems with your homecare service, contact your homecare provider directly and let your IBD team know.
Why is the change being made?
Many original biologic medicines are expensive. Biosimilars are very similar to the original medicine and have the same quality, safety and effectiveness. They are also less expensive. So the NHS can use the savings made by using biosimilars to treat more people.
Where can I find more information?
If you want to learn more about the new medications, you can find information on the EMC and MHRA websites.
The Patients Association has more information on switching to biosimilars. This includes a video about biosimilars, and a biosimilars leaflet to download.
If you have any worries about switching to a biosimilar or how it will be delivered to you, talk to your IBD team.
