Future of Health: Focus on Biosimilars – Credit NIHR
1. What are adalimumab biosimilars?
Adalimumab biosimilars are newer, highly similar versions of the original Humira.
2. Why have they been marketed?
Because Humira came off patent in the UK in October 2018. Several adalimumab biosimilars are now licensed for use. They have been thoroughly tested and gone through the same official regulatory processes for quality, safety and efficacy as the original Humira. Using adalimumab biosimilars will cost the NHS much less each year than it would for Humira. In 2018, the NHS spent £400m annually on Humira. Using adalimumab biosimilars could save the NHS around £150m a year.
3. Are the adalimumab biosimilars generic versions of Humira?
No. Biologic medicines like Humira are made from biological sources and are very complex molecules. Making an identical copy of a biologic is not possible, but biosimilars can be made.
4. Is Humira being discontinued?
5. What are the adalimumab biosimilars called?
As at February 2021, they are Amgevita, Hulio, Hyrimoz, Idacio and Imraldi.
6. Which adalimumab biosimilar will I be offered?
This depends on where in England you receive your eye care. There is a first-line and a second-line choice of adalimumab biosimilars in each NHS England region. If a citrate-containing adalimumab biosimilar is first-line, a second-line citrate-free product will also be available (see question 10 for details of which adalimumab biosimilars contain citrate).
7. Are they all available as prefilled pens and prefilled syringes?
Yes. Amgevita, Hulio, Hyrimoz, Idacio and Imraldi are all supplied as prefilled pens and prefilled syringes, all containing 40mg in 0.8ml.
8. Are the adalimumab biosimilar prefilled pens different to use compared with Humira pens?
Yes, and each brand of adalimumab biosimilar pen works slightly differently from each of the other brands of adalimumab biosimilar on the market. You need to be shown exactly how to use your particular brand of prefilled pen (see question 15).
9. What about the adalimumab biosimilar prefilled syringes compared with Humira syringes?
Most of the adalimumab biosimilar prefilled syringes either have needle shields or a needle which goes back (retracts) into the main part of the syringe once the injection is complete. Needle shields or retractable needles help to reduce the risk of accidental needle injuries.
10. Do the adalimumab biosimilars contain citrate?
Citrate in the injection liquid is what causes a stinging sensation on injection. Citrate was removed from Humira in UK some time ago, but other countries may still be using the original citrate-containing Humira.
- Amgevita and Hulio do not contain citrate.
- Idacio, Imraldi and Hyrimoz do contain citrate.
11. Do the adalimumab biosimilars have latex in them?
- The Amgevita pen, the Hyrimoz pen and the Hyrimoz syringe all have latex in their construction.
- The Amgevita syringe, and also the pens and syringes of Hulio, Humira, Idacio and Imraldi are all latex-free.
12. I’m soon going to start adalimumab treatment. Will I get Humira or an adalimumab biosimilar?
You are very likely to start your treatment with one of the adalimumab biosimilars which are currently being offered in the NHS England region where your hospital clinic is situated.
13. What length of prescription will I have for the adalimumab biosimilar?
This will be agreed with your clinic.
14. How do I get supplies of my adalimumab?
- Home care companies supply and deliver your adalimumab biosimilars. Your clinic will explain the process to you and give you contact details for your home care company.
- Your home care company may offer an online webchat service as well as phone and email contacts.
- Make a note of how to contact your home care company in case you have any problems over deliveries of your adalimumab biosimilars.
- You need to know when to expect your first delivery of your adalimumab biosimilar.
- You must also make sure you have enough of your current treatment to allow for any possible delays in receiving the first delivery of your adalimumab biosimilar.
15. Will I get training on how to use the adalimumab biosimilar?
- You will receive a telephone call from your home care company to discuss your training and to make an appointment with you for a home care company nurse to visit you and show you how to do your injections.
- Your home care company nurse will help you to give your first dose and will also be able to deal with any problems.
- Your home care company nurse will give you extra tips to help you get the best out of giving your own injections. This may include things like choosing and preparing your injection site and how long to hold the pen or syringe in place to make sure you get the full dose each time.
16. Will I always get the same brand of adlaimumab biosimilar?
- Prescribing and supply of adalimumab biosimilars in UK is done by brand name only, with no substitutions of brands allowed, so you should always receive the same product.
- However, from time to time, there will be alterations to the NHS England regional contracts for adalimumab biosimilars. This might mean switching to another brand of adalimumab biosimilar.
- Any proposed switching to another brand of adalimumab biosimilar should be explained to you by your clinic.
- Your clinic should also give you the details of any change in your homecare company and how to contact them so you can arrange training on your new brand of biosimilar pen or syringe.
17. How do I store my adalimumab biosimilar products?
They need to be kept in a refrigerator at between 2°C and 8°C. Do not freeze them.
18. Can I keep my adalimumab biosimilar out of the fridge?
- Take your adalimumab biosimilar pen or syringe out of the fridge about 30 minutes before your injection is due. This allows the product to get to room temperature before you inject it.
- Always protect your adalimumab biosimilar from light until you are ready to use it.
- If your adalimumab biosimilar dose is going to be out of the fridge for longer, for example, if you are travelling, it can be kept at a temperature no higher than 25°C (77°F) for a certain number of days.
- This number of days may be 14 days, or it may be longer, depending on the brand of adalimumab biosimilar you have and the country where you live. Check the leaflet included with your adalimumab biosimilar to find out the exact number of days your brand of adalimumab biosimilar product may be stored unrefrigerated, or ask your home care company for advice on storage.
- When you have removed a dose from the fridge but are not going to use it immediately, write on it the date when you took the dose out of the fridge and the date by which it must be used. If you have not used the product within the number of days allowed, you must discard it, even if you have put it back in a refrigerator during that time.
19. Is my birdshot likely to flare up when I switch treatment to an adalimumab biosimilar?
Adalimumab biosimilars have been in use in England since 2019. Very few people have had problems with uveitis flares after starting treatment with them. However, as with all treatments, if you notice any changes to your vision, you should contact your eye team as soon as possible for advice.
20. What if I get side-effects from the adalimumab biosimilar or I think it’s losing its effect?
Side-effects can happen with any medicine, and you should discuss these with your doctor. Loss of effect can happen with any biologic. If this happens, your doctor should review your treatment plan and discuss the next steps with you.
21. Can I switch products?
If either you or your doctor feels that your adalimumab biosimilar is not working well for you, this should be discussed, and your treatment reviewed. You may be offered the possibility of switching to a different adalimumab biosimilar.
22. If I live in Wales, but receive my eye care at a hospital in England. Which brand of adalimumab biosimilar will I get?
You will be offered the same adalimumab biosimilars that your hospital clinic in England is offering to patients who live in England who attend that clinic.
23. I’m already using an adalimumab biosimilar. What happens if I have to move my eye care to a hospital somewhere else in England?
It should be possible for you to stay on your current adalimumab biosimilar product, but this needs to be discussed fully with your new eye hospital consultant.
Information updated in March 2021 from guidance originally written to help with the switching process from Humira (adalimumab) to adalimumab biosimilars in England in 2019.