Biosimilar medicines – equivalent biological products which have no meaningful differences from the original or reference product in terms of quality, safety or efficacy – are playing an important role in providing choice for clinicians and increasing access for patients by driving down cost to the NHS. Warwick Smith, director general of the British Biosimilars Association (BBA), outlines how the UK has grown into a market leader.
The patent expiry of Humira, one of the world’s best-selling medicines, at the end of last year was rightly anticipated as a milestone moment for the biosimilars sector. A biological blockbuster used the world over was now open to competition and the introduction and uptake of alternative biosimilars was also going to be viewed as a measure of progress in the development of these important follow-on medicines.
Nearly a year on, progress been good and Adalimumab – the biosimilar name for Humira – is on course to make the single biggest contribution to the NHS objective of saving in the order of £200 million to £300 million per year by 2021. Biosimilars are here to stay and will make significant contributions to NHS sustainability moving forward.
Biological medicines are protein based and made or derived from living organisms. Unlike traditional chemical equivalents, they can be tailor-made so they bind to specific targets in the body and treat serious or chronic diseases. A biosimilar medicine is manufactured to be highly similar to an existing licensed “reference” biological medicine after expiry of its patent, with no meaningful differences in terms of quality, safety or efficacy.
Biological medicines – like Humira – have dominated global lists of the best-selling, highest cost prescription drugs. Very successful treatments for rheumatoid arthritis and autoimmune diseases have led the way and as we move forward other disease areas, such as oncology, are increasingly coming to the fore in new biosimilar medicines.
With UK healthcare budgets stretched by ageing populations, technology investment and advances – which mean diseases can be detected earlier and treated later – affordability and value are key elements of widening patient access. So, as biological medicines
have played a more significant role in providing lifesaving and life-enhancing treatments, greater uptake of biosimilar medicines is critical and this is an area where the UK will see increasing benefits over the next few years.
However, this kind of progress and cut-through has not always been the case for the UK market which just a few years ago was some way behind usage and uptake of biosimilars compared with other European countries.
Lack of comparable clinical experience and thus real word understanding had previously been among the limiting factors for biosimilar uptake. Some clinicians and patients had been more cautious to embrace them.
However, as experience has increased, so has understanding, particularly around topics such as switching patients from the originator to a biosimilar medicine, which is needed to drive the full benefit of biosimilars in enhancing patient access. NHS England has done a great job in bringing together the full range of stakeholders – NICE, the MHRA, industry groups, patient groups, doctors and nurses – to understand why biosimilar medicines should be routinely adopted, and why switching from the originator is a perfectly natural thing to do, that is underpinned by the regulatory science and now increasing real world evidence.
NHS England has issued guidance for commissioners which suggests that it should be normal for new patients to be treated with biosimilars – if they are less costly than the originator, which they normally are – and that clinicians should consider switching existing patients from the originator to a biosimilar. This kind of guidance and sharing of best practice has been key to driving further uptake across the regions of the UK. The NHS has recently published the second iteration of its “What is a biosimilar” document aimed at increasing clinical and patient awareness.
This collaboration between stakeholders has been important and we have seen the most effective uptake in the UK where commissioners and medical professionals work together to implement biosimilars and share the resulting savings across their respective institutions.
Uptake is now in a healthy state and in a relatively short space of time the UK has gone from lagging to leading. That said complacency isn’t creeping in and there is still much to do to correct regional variations and ensure patient groups and clinicians are able to learn from the experience of those that have gone before as patents expire in new therapeutic areas.
From a procurement perspective, there is also innovation being rolled out. Due to the sheer scale and cost of Humira / Adalimumab, NHS England adopted a new approach to procurement: one which prioritised competition, and therefore savings to the NHS, but also crucially focused on ensuring that there were multiple suppliers, avoiding a “winner tales all” approach. This assisted sustainability for the industry and security of supply for patients.
Learnings from these products are being taken on-board and will be translated into future biosimilar launches. Fine tuning and re-shaping future processes is important in order to deliver the right level of incentives and benefits across the system which in turn will drive uptake and savings, benefitting NHS budgets and patient access.
The biosimilars market in the UK has seen rapid acceleration in recent years and is now in a position to deliver significant savings which will increase access and support sustainability of the wider NHS.