One of the biggest events of 2018 was the expiration of Humira’s (adalimumab) patents in Europe. A wave of biosimilars entered the market looking to claim a market share shortly after. This led to significant claims on what financial savings could be made by national authorities, and an estimate that nearly 80% of patients could be switched away from Humira.
However, when BioPharma-Reporter (BPR) spoke to Warwick Smith (WS), director general of the British Biosimilars Association (BBA), he outlined that there is much work left to be done. He outlined how patient understanding of biosimilars is improving, resulting in greater uptake in the UK. However, in the US, he stated that the Food and Drug Administration (FDA) is “less far-sighted” in its submission requirements.
Ian Platts, pharmaceuticals markets analyst at BMI Research, suggested earlier this year that this may be due to the biosimilar market being “new and largely untapped.”
Smith remained positive about the future for biosimilars, particularly about the strength that had been shown of the market in the UK in 2018.
BPR: How was 2018 for the biosimilar industry?
WS: It was a really good year, in a number of ways. We saw a very significant take-up of biosimilars during the year. In the UK, we've gone from being one of the laggards in Europe, two or three years ago, to being a leading light. We're now at 90% market penetration of infliximab [Johnson & Johnson's Remicade], which is generic levels of use. I've seen some NHS data that suggests we're looking at treating a third more people, at half the cost – that's really important for the NHS and patients, as well as for the biosimilar industry.
BPR: What was the standout event of the year?
WS: The thing that everyone looked at, in 2018, was the launch of adalimumab biosimilars, as the patent on Humira expired. It is a little early to talk about outcomes, given that the patent has only just expired and the tender process only began on December 1. What I would call attention to is the effort NHS England went to, in order to define a new procurement process, which ensured that lots of suppliers on the market. I think the focus on the plurality of supply, rather than just price, was a really good thing. NHS was keen that there shouldn't be a 'race to the bottom', so that one manufacturer got the whole country, as it were. This [process] is something we support, we will have to see how this works in practice but 10/10 for the principal.
BPR: Why did the NHS pursue this procurement method?
WS: There has always been agreement between ourselves [BBA] and the NHS that the market works best when there is competition in it – replacing a monopoly originator with a monopoly follow-on manufacturer, either biosimilar or generic, isn't great. Plurality of supply brings a number of benefits. The competition provides lower prices but it also means that if a manufacturer encounters issues then there are others that can supply the equivalent medicine.
BPR: Will sharing the marketplace make it more sustainable in the long-term?
WS: It costs a lot more to develop a biosimilar than a generic. There has to be a reasonable expectation of getting a return on that investment to ensure that the market remains sustainable. In the case of adalimumab, there were four biosimilars available for launch at patent expiry – if only one of those had gained 90% of the market then you could see the other three, on the next patent expiry, thinking: "Is this a commercial risk we want to take?" Ensuring that there is an opportunity for all, albeit that opportunity is bigger if your price is more competitive, has to make sense.
BPR: Do you think the public's understanding of biosimilars is improving?
WS: I think it still needs to be worked upon but I think there is a greater understanding. I think if you look at the change of biosimilar use in the UK, going from near the bottom of the list across Europe to being towards the top, this has been largely due to increased education and understanding.
NHS England created the 'NHS England biosimilar medicine programme board', which brought together everybody involved: BBA, ABPI, NHS England, NICE, MHRA, patient groups, clinicians, nurses and so on. [The board] has been able to do advise as a group on the sort of information that should be made available to the public. This was important to 'demystify' biosimilar medicines.
I think as biosimilars have been used in practice and real world evidence has become available, in some disease areas, the confidence in them seems to have translated to new launches. People at the sharp end love real world evidence. So, the greater the success achieved then the greater it becomes.
BPR: What other challenges are being faced?
WS: I think we have to recognise that there is a cost initially in switching a patient from an originator product to a biosimilar. The cost is largely around human resources and having the necessary conversations with patients, as well as additional pharmacovigilance. Ensuring that the financial benefits and potential benefits to patients, in the ability to treat a greater number of them, then making that clear to clinicians is important.
BPR: There have been examples of companies not taking developed biosimilars through the regulatory process recently – why is that?
WS: There are significant differences between the regulatory process in Europe and the US. The European Commission was the first to develop a regulatory path for biosimilars in Europe, it did that in recognition of the science and the importance of launching these products. I think, frankly, the FDA has been less far-sighted and looks for a level of proof that is beyond that which other regulators would look for. I do think they ask for unreasonable levels of research and data. If you look at the success experienced in Europe, in terms of take-up and the reaction of patients, we have seen the European regulatory standard ensures meaningful clinical differences.
Another point is that if you get a 'race to the bottom' – very low prices for the company that feels it has to be in the market – that is not a sustainable market. The procurement system that NHS England for adalimumab is a way of getting around that. A crazily low price will lead to people taking the decision that [biosimilar development] isn't worthwhile.
BPR: What does the landscape looks like for biosimilars in 2019?
WS: Governments and payers across Europe see the benefits of biosimilars. I would say, in terms of take-up and use, that there is more work to be done in some other European countries and I would expect that to happen.
If I switch to Brexit, all biosimilars are approved by the European Commission; if the UK manages to remain part of the European 'regulatory family' then that mechanism could still exist so that would be all well and good. If not, there isn't yet a defined regulatory pathway for biosimilars in the UK. The MHRA has said that it would not require further development to be done and they would want to respond to the same dossier files put into the EMA.
However, if companies have to answer two sets of questions that, of itself, becomes a barrier. When the UK says, "We'll do it faster", then most of our members respond, "No, don't do it faster! Do it at the same pace." Doing it faster means that members would need two people answering questions instead of just one. As common an approach as possible is needed to ensure that the flow of new biosimilar and generic medicines continues.