Biosimilars bring price pressure, but are they sufficiently used?
Av In recent decades, biological drugs have, in many cases, revolutionised the treatment of patients with, among other things, cancer, diabetes and rheumatism.
The problem is that they are often very expensive, which has partly imposed high costs on society, and partly meant a risk that not all patients who were suitable for the treatment could be offered one.
However, since 2006 biosimilars have been allowed. Biosimilars are a kind of similar copy of biological drugs that can be introduced after the original drug’s patent has expired, and then usually at a significantly lower price.
There are currently around 70 biosimilars that are approved within the EU, many of which are treatments for autoimmune diseases in the rheumatology field.
But have the biosimilars led to more patients receiving the best possible treatment?
“Yes, I would say so, simply because the biosimilars have lowered the general price level of the medicines. This means that regardless of whether we use an original drug or a biosimilar for treatment, the cost to society is lower, and we can thus lower the bar for when we should use these drugs,” says Johan Askling, Professor of Rheumatology at the Karolinska Institute and Senior Physician at Karolinska University Hospital.
Since biological drugs consist of large and complex molecules, it is impossible to create an exact copy. A biosimilar must demonstrate similarity in safety and efficacy when treating patients with an already approved biological drug in order to be approved.
However, the Swedish Association of Rheumatology has not been content with this criterion but has carried out its own register-based follow-ups to check that the biosimilars in the field work equivalently to the reference medicines.
The bottom line: yes, the biosimilars tested so far do measure up.
“This was crucial for our credibility and responsibility for the patients. Otherwise, it would have been very difficult to justify to patients why they should switch from a drug they have used and felt good about for several years to another type that is said to be equivalent but is cheaper,” says Johan Askling.
But are the biosimilars sufficiently used? Not if you ask Sandoz, which is part of Novartis and markets seven different biosimilars in Sweden.
The company regularly produces reports on the development in the field and publishes a “biosimilar index”, which reflects the number of defined daily doses of all biosimilars on the Swedish market divided by the total number of defined daily doses for the substances in question.
During the first quarter of 2022, Sweden reached an index of 60, where 100 would mean that biosimilars had the entire market for all biological medicines that have lost their patent.
“We started with this approach because some regions still do not fully use biosimilars. They are slow to switch to biosimilars, and sometimes they even continue to prescribe the reference drugs to new patients, even though they are five to six times more expensive than the biosimilars in some cases,” says Tobias Cassel, Head of Public Affairs at Sandoz Nordics and also Chairman of the Biosimilars Group at the Association for Generic Medicines and Biosimilars (FGL).
Admittedly, the Sandoz biosimilar index has risen from 30 to 60 in the last six years, but Tobias Cassel thinks that progress is too slow, which means that tax money continues to be wasted.
“Time and time again, the authorities argue that we will not be able to afford all the new drugs that are coming, but before making that priority, these savings must be ensured as a minimum. It is a matter of several hundred million SEK that have not been realised,” he says.
Johan Askling would like to nuance that statement.
“In my view, biosimilars have made a big impact, at least in my own discipline. You could probably use them more and skimp even more, but the question is whether it is worth it. It is an absolutely logical switch if you can lower the cost from SEK 100,000 to SEK 30,000. However, if you go from SEK 30,000 to SEK 27,000, or from 27,000 to 26,500... well, then you have to take into account that the switch itself is not free, as you need to contact the patient, explain, sometimes convince and ensure that there is no misunderstanding and so on.”
He also points out that the “ideal situation”, i.e. when you always choose the cheapest option at the moment, entails the risk of so-called multiple switching: that the patient is sent in rotation between the different medicines.
“We don’t know for sure today, but we suspect that it might trigger a loss of effect.”
Another aspect to consider is the patient’s own will. It is not common, but it does happen that patients do not want to switch to a different cheaper treatment.
“I think that anyone who puts themselves in the situation will realise that it is not an obvious choice. If you have high-cost insurance and have had a terrible medical history, which you finally got through thanks to an original drug, who would then first and foremost be in solidarity with the social apparatus and mortgage their ability to function in favour of a cost-saving of and often unknown size? You had better be in possession of very well-documented facts to be able to say that such a drug switch will not mean an increased risk of side effects or lost effect of the treatment,” says Johan Askling.
Facts: Biosimilars
Biologic drugs are proteins, usually produced in living cells in a biological process. They are large, complex molecular structures that are harder to characterise than chemically produced, synthetic drugs with a definite molecular structure.
When the patent term for a biological drug expires, other companies may manufacture “copies” and get them approved as biosimilars. Since biosimilars are produced in living organisms, minor differences may occur between a biosimilar and the original drug, and these differences must not be clinically significant.
Since biological drugs and biosimilars are not identical, current regulations do not let pharmacies automatically replace biological drugs in the same way as chemical drugs. Switching between biologics should be initiated by the attending physician.
Source: TLV, Lif
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