Biosimilars to Humira (adalimumab) – Q&As

Information prepared by Birdshot Uveitis Society (BUS) February 2019 for people receiving adalimumab treatment in UK

Note: These Q&As describe the situation in England, particularly on the switching process from Humira (adalimumab) to an adalimumab biosimilar. BUS does not have details of the switching process in Wales, Scotland and Northern Ireland. However, we hope that these Q&As may be helpful to you wherever you live in the UK.

Future of Health: Focus on Biosimilars – Credit NIHR

Products

What are adalimumab biosimilars?

Adalimumab biosimilars are newer, highly similar versions of the original Humira. 

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. Currently, the NHS spends £400m annually on Humira. Using adalimumab biosimilars could save the NHS around £150m a year.

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. 

Is Humira being discontinued?

No.  

What are the adalimumab biosimilars called?

Those available in the UK at the end of 2018 are called Amgevita, Hulio, Hyrimoz and Imraldi.

Which adalimumab biosimilar will I be offered?

This depends on where in England you receive your eye care. There will be 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 later for details of which adalimumab biosimilars contain citrate). You and your doctor should discuss what is available to you before making any prescribing or switching decision.

Are they all available as prefilled pens and prefilled syringes?

Yes. Amgevita, Hulio, Hyrimoz and Imraldi are all supplied as pens and syringes, all containing 40mg in 0.8ml. 

Are the adalimumab biosimilar prefilled pens different to use compared with Humira pens? 

The Amgevita, Hulio, Hyrimoz and Imraldi pens start with a loud click and have a small window on the pen which changes colour when the injection is completed. The Hulio pen also gives a second click when the injection is finished.

What about the adalimumab biosimilar prefilled syringes compared with Humira syringes?

The Humira syringe has a needle shield. The Amgevita, Imraldi, Hyrimoz and Hulio syringes all have a needle which goes back (retracts) into the main part of the syringe once the injection has finished. A needle shield or a retractable needle helps reduce the risk of accidental needle injuries.

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, so Humira does not now sting. 

  • Amgevita and Hulio do not contain citrate. 
  • Imraldi and Hyrimoz do contain citrate.

Do the adalimumab biosimilars have latex in them?

The Amgevita pen and the Hyrimoz syringe and pen all have latex in their construction. The Amgevita syringe, also the Hulio and Imraldi syringes and pens, are all latex-free, as are Humira syringes and pens.

New patients

I’m soon going to start adalimumab treatment. Will I get Humira or an adalimumab biosimilar?

You are very likely to start your treatment on one of the adalimumab biosimilars which are currently being offered in the NHS England region where your hospital clinic is situated.

What about the dose of adalimumab I’m to have?

Humira and each of the adalimumab biosimilars all have the same first (loading) dose, maintenance doses and intervals between doses.

Switching to an adalimumab biosimilar

Am I going to be switched from Humira to an adalimumab biosimilar?

Not without your doctor first having a discussion with you about it. There will be no automatic switching from Humira to an adalimumab biosimilar, but the subject of switching is likely to be raised with you. 

What’s the switching process?

You should first receive a letter from your doctor with information about adalimumab biosimilars, giving some idea of when your clinic is planning to carry out switching. You should then be given the opportunity to discuss your condition and your needs with your doctor. You should also receive an explanation and description of the pens and syringes of the adalimumab biosimilar brands available in the region where your clinic is situated. You may be asked to sign a patient information form to say that you have agreed to a switch to an adalimumab biosimilar and be given a copy of that form.

Do I have to switch from Humira?

After discussion with your doctor, most people should be suitable to switch to an adalimumab biosimilar and agree to this, but, depending on your medical history, your doctor may decide with you that you should continue to receive Humira.

If I’m switched, will I continue to get the same brand?

Prescribing and supply of adalimumab biosimilars will be done by brand name only, with no substitutions of brands allowed. However, from time to time, there will be alterations to the NHS England regional contracts for adalimumab biosimilars. This may mean switching to another brand of adalimumab biosimilar, or you may stay on your current brand product. Any proposed switching to another brand of adalimumab biosimilar should be explained to you in the same way that the first switch was done, with agreement between you and your doctor on which adalimumab biosimilar you should receive.

Will I get my adalimumab biosimilar from the same homecare company that supplied my Humira? 

Your homecare company may stay the same, or it could change. Either way, you should be told about this by your clinic. If not, you should ask for this information before you leave the clinic. Check that you know how to contact the homecare company and who to speak to about deliveries and about training on using the new product. In particular, you need to know when to expect your first delivery, and to make sure you have enough of your original Humira to allow for any possible delays in receiving your first supply of adalimumab biosimilar.

Will I get training on how to use the adalimumab biosimilar?

Everyone switching to an adalimumab biosimilar should be offered a telephone call from a homecare nurse to discuss any training needs you may have on using your new syringe or pen. If you feel you may need help, the homecare nurse can follow up the phone call with a home visit.

What length of prescription will I have for the adalimumab biosimilar?

This needs to be agreed with your doctor, but the amount of medicines prescribed and delivered to you is unlikely to change from the arrangements you have for Humira.

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. 

Can I switch back?

If either you or your doctor feels that the 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 or switching back to Humira.

I live in Wales but get my eye care at a hospital in England. What will happen to me about switching to an adalimumab biosimilar?

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.

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.