If the first biosimilar was approved in 2006, why have biosimilars only really been attracting the headlines in the last few years? I think there are two key factors now putting biosimilars firmly in the limelight.
The first is the rate of drug discovery and innovation in general, and the associated budget impact which continues to grow exponentially. In 2016 alone, there were approximately 30 oncology drugs in late stage development for breast cancer, leukaemia, lung cancer and ovarian cancer. Budgets in most health economies just cannot keep up with this pace of innovation, so affordability and access to these new medicines has never been more challenging. Biologics represent a significant proportion of these innovative medicines and a substantial portion of the global drugs budget. In 2016 biologics accounted for 17% of global medicines spend – that’s about €175bn. If we project forward to 2020, seven of the top 10 global medicines by spend will be biologics.
The second factor is the exponential increase in biosimilar approvals. In 2016/17, the European Medicines Agency approved around 20 biosimilars – that’s as many as were approved in the preceding nine years. If we take the top 20 biologics by spend, in two years, 15 of these will have biosimilars. Their increasing number and potential to tackle the affordability challenge is bringing biosimilars centre stage.
As well as facilitating access to new innovative medicines, biosimilars also improve access to existing biological medicines. For example, since 2015, when the first monoclonal antibody biosimilar, infliximab, was launched in Europe we have seen a notable increase in the overall use of infliximab.
Another driver for biosimilar adoption in some countries such as the UK is ‘gain share’. Here, agreements to share associated savings between payers and healthcare professionals (HCPs) have seen re-investment by HCPs into improved care delivery, such as recruitment of additional specialist nurses.
Driving disparity
If we look across Europe at biosimilar penetration, even the recently launched infliximab and etanercept biosimilars show highly variable uptake between markets. Notwithstanding some of the intellectual property challenges we see in the US, biosimilar adoption is largely being driven by prescribing policy and HCP acceptability. National policy mandates to switch from the originator to biosimilars, as has been the case in Norway, have resulted in rapid and almost complete biosimilar market penetration.
However, most countries have a regionalised policy approach to prescribing biosimilars and here, HCP acceptability is critical. We know that HCPs who are not convinced of the biosimilar concept, whether they be physicians or specialist nurses, represent a significant barrier to their adoption and can negatively influence colleagues.
The role of medical education
From our experience, medical education plays a central role in supporting and accelerating biosimilar adoption. Where the HCP community has limited biosimilar experience, medical education needs to simplify and communicate some relatively complex concepts: what biosimilars are, their unique regulatory and approval process and the principle of extrapolating data from an initial biosimilar indication to all indications approved for the originator.
Beyond communicating ‘what’ biosimilars are, medical education programmes need to highlight the ‘why?’, bringing the benefits of adoption to life. We find that peer-to-peer programmes are critical, providing the opportunity for HCPs to hear from early adopters and understand ‘what’s in it for me, my patients and my local health economy?’
Similarly, we have seen that programmes helping early adopters to share ‘how’ they introduced biosimilars in their units are being highly valued by their peers. It gives them the opportunity to find out ‘who’ and ‘what’ is involved, as well as learning from the early adopters’ positive experiences and even their mistakes. HCPs particularly welcome this kind of sharing experience when it comes to switching patients from the originator to a biosimilar. In chronic diseases such as rheumatoid arthritis and inflammatory bowel disease, there are significantly greater savings from switching patients compared with initiating biosimilars in naïve patients alone. However, the ‘switch’ process requires leadership, planning and effective stakeholder management, including a well-coordinated dialogue with patients.
Once medical communities are ‘biosimilar experienced’ there is little need for programmes to tackle the ‘what, why and how’ when subsequent biosimilars become available. Then the focus will be ‘why this biosimilar?’ Sharing real-world evidence, as well as HCP and patient experience is crucial for all biosimilars, whether they are first or fourth to the market.
Medical societies emphasise that switching to a biosimilar should involve a discussion between HCPs and their patients. What’s the value of medical education here?
HCPs tell us that getting this ‘switch’ discussion right with patients is extremely important. First and foremost, patients must be reassured the biosimilar is not an inferior medicine and that it has proven safety and efficacy evidence for its use. Some HCPs describe the biosimilar as the latest or most recent version of the drug to reinforce patient confidence.
Not surprisingly, HCP acceptability is the key determinant of patient acceptability. Patients are much more likely to accept switching from the originator to a biosimilar if the HCP is confident, clearly endorses the change and provides reassurance. Some clinicians find it helpful to highlight that switching allows more people to access this medicine as well as newer, more expensive medicines as they become available.
In contrast, where HCPs present a ‘glass half-empty’ view of switching, such as ‘shrinking budgets means we are using this cheaper version’, it will negatively impact upon patients. When conditioned to expect a negative response, otherwise known as the ‘nocebo’ effect, patients are more likely to report adverse events, putting a brake on biosimilar adoption.
Getting the discussion right requires time and careful planning. Here medical education can support HCPs by providing high quality patient materials which introduce and provide reassurance about the biosimilar treatment. This allows the HCP-patient discussion to focus on patients’ outstanding questions and concerns.
With the large number of biosimilars being launched over the next few years, who will be the winners and losers?
Costs of developing a biosimilar and obtaining regulatory approval are considerably greater than for a generic. Consequently, a biosimilars market defined purely by price, as we see in the generic market, will be unsustainable.
The benefit of value-added services
One approach to differentiate beyond price and provide sustainability is incorporating value-added services (VAS) as part of the biosimilar proposition. The ‘added value’ needs to resonate not only with clinicians but with budget holders too. For example, providing therapeutic drug monitoring (TDM) to minimise loss of response in patients receiving monoclonal antibodies, thereby delaying the need to introduce more expensive treatments, is an important benefit recognised by both groups.
Another route for biosimilar differentiation is the development of biobetters – a biosimilar that offers clear benefit over its originator, such as easier administration or improved immunogenicity. It will be interesting to see whether they will be able to affect a price premium over its originator and biosimilars. For both biobetters and VAS, medical education has a more traditional role in getting stakeholders to understand and value the benefits they provide.
I believe we are now at a tipping point for biosimilars. Put simply, biosimilars enable innovation at a time when the mismatch between the rate of drug discovery and affordability has never been greater. The winners will be those who accelerate adoption, provide sustainable differentiation beyond price through integrated medical education programmes and effective value-added services, as well as maximise the biobetter opportunity.