Since blockbusting drug Humira’s patent expired in late 2018, a number of biosimilar generics have entered the market, saving the NHS considerable expense. But patients like myself, who were switched to the cheaper equivalent biosimilar Amgevita, have felt let down by the lack of choice, the process of switching, the quality and efficacy of these biosimilars and are fighting to be reverted to the originator medication.
Behold, Humira — the wonder drug
Adalimumab, previously sold under the brand name Humira, is an injecting medication for patients with Crohn’s disease, ulcerative colitis, rheumatoid arthritis and psoriasis, amongst other chronic auto-immune conditions.
The advent of Humira made its manufacturer AbbVie, very wealthy indeed. Humira became one of the best selling drugs in the world only 2 years after its FDA approval. This game-changing medication quickly climbed up the pharma charts, making billion-dollar global sales and earning itself “blockbuster” status in the industry.
For many patients like myself, with auto-immune diseases, Humira was considered something of a wonder drug. Prior to this biologic medication, my Crohn’s disease was poorly managed. I spent the majority of my twenties hopping between failing medications, fire-fighting flare-ups with aggressive steroids and struggling to live the normal twenty-something life of building a career, travelling, going out and all those other nice normal things.
I started taking Humira three years ago aged 28 and although my Crohn’s disease remained moderately active it finally gave me the stability to live a relatively normal life.
Back in February of this year, I received a letter from my clinical team advising me that my Humira was to be switched to a biosimilar named Amgevita - a generic equivalent of the faithful drug that I had become accustomed to. However, this letter also came with the glowing news that this switch was going to “save the NHS hundreds of millions”. So as a patient who heavily relies upon the health service and is keen on preserving its future, I wasn’t going to grumble about this minor change to my drug regimen, especially if it meant these funds could be redirected into patient care.
The NHS website also helpfully outlines the recent switch to biosimilar medication in more detail for patients to reassure themselves:
Biosimilar medicines generally cost less than the “original brand” biological medicine, but they’re just as safe and effective. Switching patients from the original biological medicine to a biosimilar could save the NHS hundreds of millions of pounds. And you shouldn’t notice any difference — your body should respond in the same way to the newer version of the medicine.
However, it appears that many patients are noticing a difference, particularly ones who have been switched from the originator Humira to the generic Amgevita — more about that later.
Why are biosimilars so cost-saving?
The typical life cycle of a pioneering drug like Humira begins with biopharmaceutical research companies extensive testings, eventually leading to clinical trials. If successful, the manufacturer presents its studies, applies for FDA approval and the drug is often patented well before it even enters the market. So in the case of AbbVie’s Humira it was protected for around 14 years before its patent was released to other pharmaceutical companies to copy into ‘generics’ or ‘biosimilars’. During this patented period, the manufacturer of the originator brand drug has the monopoly and the price of the drug reflects this at a costly premium.
Once the patent is released manufacturers of generics have comparatively lower costs to contend with because the originator medication laid much of the ground-work in the costly research phase of the drug. Generic companies don’t need to carry out nearly as many studies and that’s why they can be offered at a much cheaper cost, hence offering substantial savings to the prescribing NHS. There is often a race to market once the patent is released, and in the case of Humira, Amgen’s Amgevita was first past the post.
Were patients given a choice about this switch?
The recent switch of many biosimilars has thrown up a number of issues in patient care. I wasn’t personally given the choice to switch to Amgevita, just sent a (non-verbal) letter advising me it was happening.
This recent study published in the pharmaceutical journal finds that “Less than half of patients (47%) were asked for their consent before being switched to an adalimumab biosimilar”
The NHS site advises patients that “you should be offered a conversation with your doctor or specialist nurse before you’re prescribed a biosimilar” but this was not the experience for the majority patients.”
A series of briefings were developed by NHS England and NHS Improvement and published on the Specialist Pharmacy Service (SPS) website. One such briefing published in July 2019 stated:
“Clear, verbal communication is an important element of high-quality patient care and shared decision making. Patient experience is one of the three key parts of clinical quality (alongside clinical safety and clinical effectiveness).” It also stated: “No changes in therapy should be implemented without patient agreement.”
Okay, so I wasn’t explicitly asked to give my consent, but it’s saving the NHS money so that’s great and Amgevita is essentially the same drug, right?
Since switching from Humira to Amgevita in February 2019 I, personally noticed a number of differences. Almost immediately my Crohn’s symptoms seemed less controlled. I was frequenting the toilet more often and my energy levels dipped considerably. Most obviously, I started experiencing visible knocks to my immune system, causing me to contract a string of infections and viruses — from a random outbreak of Cellulitis to a sudden barrage of verrucas, to giant infected finger. Each time a biologic patient is faced with an infection, they are required to pause the administration of the drug until the infection clears. So I’ve been stop-starting Amgevita for the past 7 months and my Crohns disease symptoms have resurfaced.
When I reported my concerns about the efficacy of Amgevita to my clinical team, I was met with some scepticism by both my doctor and my IBD nurses. My doctor insisted that many patients have found the effectiveness of the drug to be equal. And the nurse, in an email correspondence, explained:
“Amgevita is essentially the same drug. Similar to buying various brands of paracetamol.”
This oversimplified, rather patronizing comparison to other generic medications doesn’t accurately reflect the complexity of biologics, like Adalimumab, which are carefully made from human cell antibodies.
The website Arthritis Health rather more accurately outlines how biosimilars compare to other generics:
“Biologic therapies cannot be made using a simple chemical reaction, such as mixing ingredients together in a laboratory, the way conventional drugs are made. Instead, biologic therapies are made using living organisms, such as bacteria, yeast, and even mammalian tissue and cells. Even small differences in the manufacturing and packaging process — as well as storage and administration — of a biologic can affect a drug’s ability to work.”
So on the matter of drug administration, how does Amgevita compare?
Just like Humira, Amgevtia is administered via a self-injecting pen on a fortnightly, or in my case weekly basis. The round needle tip end of the pen needs to be pushed down into the stomach or thigh muscle at ninety degrees, and a button at the base of the pen is depressed to sound a click and a ten-second pause is advised to release the medication into the patient.
In the initial formula of Humira, many patients reported a painful sting followed by irritated raised skin around the injection site. Having listened to patients, Abbvie modified their formulation to remove the citrate buffer and reduced the injection volume in an attempt to reduce the incidence of injection site reactions.
In spite of being citrate free, the biosimilar Amgevtia now carries this sting, setting patients back to a familiar discomfort from past drug versions. In addition, the contact tip at the needle-end of the pen rather unhelpfully contains latex, which has caused allergic reactions in some patients who were not appropriately advised or aware of this material.
However, the majority of concerns are about the quality of the pen itself. In my three years of injecting Humira, I never once experienced a faulty or defective pen. In just six months of Amgevita, I have had to report 4 failed pens. The button release is often stunted or jammed, the click sounds but the needle remains precariously fixed and other patients in my support group have reported the same.
These faulty pens are likely costing the NHS in wastage and certainly costing in patient confidence.
So painful and badly made injections pens aside, my team assure me the drug is practically the same, so am I just unlucky with my experience?
Seeking out answers, I took to the internet and discovered Amgevita Support Group on Facebook. In spite of being told by my clinical team that Amgevita is the same as Humira — there appeared to be numerous patient experiences expressing the contrary? While Amgevita is indeed proven effective for many patients, there seem to be plenty of ‘switchers’ who’s difficulties read similar to mine.
“My son was switched from Humira (with no side effects) to Amgevita for his Crohns in February 2019. Firstly he found the Amgevita incredibly painful compared to Humira. We had two faulty pens that wouldn’t inject out of 6 delivered. Then there were the symptoms. For the whole two months my son was on Amgevita he experienced the following side effects: Sore throat constantly, swollen glands, mouth ulcers, skin conditions such as fungal infection under his armpits, ringworm on his forehead and eczema and impetigo on his chin, fatigue, headaches, nausea, tummy ache. Our GP felt it had totally run him down and lowered his immune system too much. He was in remission on Humira but felt absolutely terrible on Amgevita. After two months he refused to have any more injections and I had to beg his consultant to switch him back to Humira. They did and he is really well again now, back to where he was before.”
“I started Humira in September 2018, it worked perfectly and I was healthy on it. I switched in Amgevita on the 1st April and started going downhill. By mid-May, I had a full Crohns flare and by the end of June I was back on steroids. I had an appointment yesterday and they feel that the injections have failed, I feel it’s been going downhill since starting on the Amgevita.”
“I started Humira in April 2018 for Ankylosing Spondylitis and recurrent Uveitis switched to Amgevita in February 2019. I had hot flushes after the first injection which quickly turned to mild flu symptoms which then turned to severe flu symptoms. Finally leading to muscle weakness, random twitches, and patches of burning sensations on my skin. I felt completely drained of energy, body like lead, throbbing pains down both legs, severe pain in both feet -can’t walk flat-footed at all, sore gums, loss of appetite, severe constipation, hot flushes every half hour, dizzy light-headed and completely wiped out. I’ve honestly never felt so unwell”
“I was on Humira for 3 months and it began to work for me. I have Crohn’s disease and my toilet visits went from 4 times daily to once a day. I was then switched to Amgevita and my toilet visits are now 2/3 times daily so it’s definitely not working as well as Humira.”
“Amgevita flared my skin up and also gave me bad eczema. Also been feeling very run down and tired. My consultant explained how they are both similar biometrics but do have differences and she has seen several people reacting badly to these differences.”
And these are just a handful of stories shared in the facebook group.
So the patients in my support group are now being reverted back to Humira, so why can’t I?
Other patients who have experienced side effects or decreased efficacy with Amgevita are being given the option to revert back to Humira. But following an email with my IBD nurse I was told:
“It’s physically not a possibility for us anymore, Humira is not on our pathway of approved drugs. So, unfortunately, this isn’t something our trust can do. Other parts of the country may be different, but the North Central London pathway doesn’t have it on at all I’m afraid.”
It seems unacceptable that a patient can be taken off an effective drug, replaced with one that is less effective and of much poorer quality in terms of administration and then refused to return the drug, which was proving to be effective and especially unacceptable when other patients are being given this option.
It’s disgraceful that I am having to seriously consider switching hospitals just to be re-prescribed Humira. Surely all patients should have equal rights to medication, no matter their location or hospital, otherwise, isn’t it discriminatory and essentially postcode lottery in patient care?
This medical review on biosimilars concludes that listening to the experience of patients is a crucial element in reviewing the efficacy of biosimilars:
“As with…biosimilars already on the market, real-world data and pharmacovigilance studies are critical to developing long-term evidence to provide assurances on efficacy as well as safety.”
This notion of shared decision making is not something I have experienced with my team.
Having shared my experiences and concerns about Amgevita with them, the only option being offered is to start an entirely new biologic drug, unrelated to Humira / Adalimumab altogether. Starting a new drug is an uncertain process. It can take up to 6 months to give a new medication a fair chance to work and of course, if it doesn’t it’s wasted time and will have costed me another year of unsettling life limbo. My wishes to plan my honeymoon and start a family continue to be halted while I wait to see which drug awaits me next.
Something about that doesn’t seem right or fair at all.