If you have IBD and you’ve previously been on a biologic, you’ve probably heard the term “biosimilar” before. But what does it actually mean? Is it the same thing as a biologic? Researching these concepts online can seem complicated with all the medical jargon that websites tend to use, so here is everything you need to know about biosimilars.
First of all, let’s get back to basics and talk a little bit about what a biologic is. Put simply, a biologic is a type of treatment for certain long-term health conditions like Crohn’s disease and rheumatoid arthritis. Biologics are usually given as infusions or sub-cutaneous (under the skin) injections.
In terms of the actual medicines themselves, according to the NHS, a biologic is “made from proteins and other substances produced by the body.”
The inflammation associated with IBD is caused by an overactive immune system response. Broadly speaking, biologics work by interrupting immune system signals in order to reduce inflammation.
Some examples of already approved biologics for the treatment of IBD include: Adalimumab, Infliximab, Ustekinumab and Vedolizumab. These are the names of the “generic drugs”, but biologics are produced under brand-names like Humira (Adalimumab), Remicade (Infliximab), Sterala (Ustekinumab) and Entyvio (Vedolizumab).
These drugs work in different ways but with the same goal of reducing IBD inflammation. Adalimumab and Infliximab are what’s known as anti-TNF drugs. They bind to a protein called TNF-alpha which is thought to be overproduced in IBD patients, therefore reducing inflammation. Ustekinumab works in a similar way, but it is known as an anti-interleukin drug. It targets the proteins interleukin-12 and interleukin-23 which contribute to ongoing inflammation in the gut, rendering them inactive and preventing inflammation. Vedolizumab on the other hand is an anti-integrin drug. It works by stopping the white blood cells from entering the lining of the gut and provoking inflammation.
So, now we know what biologics are, we can move on to biosimilars. A biosimilar is essentially a “newer version” of the original biological drugs listed above. Some biosimilars which probably sound familiar include: Hymiroz (biosimilar of Humira) and Remsima (biosimilar of Remicade).
These biosimilars are not exact copies of the generic drugs. According to the Biosimilars Resource Center, “a generic drug is chemically identical to its brand-name counterpart- an exact copy… A biosimilar may have a different structure than the reference product, but the active substances are essentially the same in molecular and biological terms. This means that there are no clinically meaningful differences between the biosimilar and reference product in terms of safety or effectiveness.”
So, all that basically means that biosimilars, whilst potentially being formed of slightly altered structures, perform equally well and are just as safe as their generic counterparts. In the context of an example, this means that Humira is an exact copy of Adalimumab. Hymiroz on the other hand might differ slightly but is a perfectly safe and effective biosimilar alternative to Humira.
All biosimilars have to undertake the same tests and clinical studies in order to be approved for use with patients so, if you have recently been swapped to a biosimilar, you shouldn’t be worried that the drug won’t be work as well as the original, or that it might be dangerous- you are safe!
So, if these drugs are of comparable safety and effectiveness, you might be asking: What’s the point in swapping to a biosimilar? And the answer is relatively simple: they are MUCH cheaper than generic drugs. The NHS claims that: “through making biosimilar medicines more quickly available the NHS will by 2021 be able to take advantage of up to £300m of savings each year.” Wow, that is a lot! Apparently, because before biosimilars there was only one generic drug that could be prescribed for all patients in need of that biologic treatment, six of the top 10 medicines in terms of cost were biological drugs.
Let’s take a look at Adalimumab in particular. It was named the most expensive drug in UK hospitals, costing around £400 million a year. Sheesh! By swapping 80% of the 46,000 patients prescribed the drug to a biosimilar in 2018, the NHS aimed to save £150 million a year by 2021. I suppose we shall see next year if they will reach this target!
By saving such a significant amount of money, more patients will gain access to life-saving medications provided by the NHS, so biosimilars are a very attractive option.
If you want to know whether you are on a generic drug or a biosimilar, there are several ways to find out. If you take sub-cutaneous injections, the name of the drug/ biosimilar will be written on the syringe. If you are given infusions, you may notice the name of the drug/ biosimilar on the drip bag. Otherwise, feel free to check with your consultants or the specialist nurse in charge of your care. Your IBD team shouldn’t swap from a generic drug like Humira to a biosimilar like Hymiroz without consulting and informing you about the swap first. Personally, I was given a few information leaflets regarding my swap and everything was clear and simple.
And that’s all there is to it really! I hope you found this guide useful, but if you would like some more information, you can have a read of the following websites:
https://www.crohnsandcolitis.org.uk/about-crohns-and-colitis/publications/biologic-medicines
https://www.england.nhs.uk/medicines-2/biosimilar-medicines/
https://www.biosimilarsresourcecenter.org/faq/what-are-biosimilars/
Me and My Crohn's 