Biosimilars have to be one of the most anticipated types of medicines, but not because they do anything new clinically for the patient. In fact, that’s the point – they are expected (and regulated) to perform very similarly to the medicine upon which they are based. Note the difference – they are to perform “very similarly” and not “identically”.
That is because these are biological medicines developed and produced in living systems (cell lines) and it is not possible to generate an identical copy. In this respect (amongst many) biosimilars are not like generics. However, the anticipation does come from a hope that like generics, biosimilars will bring additional competition for a particular medicine when it has lost all of its exclusivities. The windfall of savings that have been generated by generics have whetted the appetites of health systems around the world, including in the UK, for what biosimilars might bring.
Ten years since regulatory guidance was first published in Europe and nearly 10 years since the first biosimilar was launched, the impatience for biosimilars and the savings they might deliver for health systems is palpable. For example, Sarah Houlton's latest article Pills, prices and politics reports that "it's been a long road to market for biosimilars", and quotes one IMS IHI report, Global use of medicines in 2020 to conclude that cost pressures in healthcare systems will drive new funding models. That debate is really picking up pace in the US, where the first biosimilar was approved in 2015. Last month, the White House and the Department of Health & Human Services (HHS) hosted a forum to discuss healthcare costs and the calls were to ensure biosimilars were part of that discussion.
Too late for that forum but well in time for discussions in the UK and elsewhere, IMS has published this week its report for the European Commission on the impact of biosimilar competition in Europe, as well as five conclusions that IMS has drawn from the analysis, which describes the effects of price, volume and market share following the market entry of biosimilars. The IMS Health team conclude:
Although many of these observations have been described previously or anticipated, the real message in these observations is that the impact of biosimilar competition depends on where you start (e.g. the market for medicines in that class of treatment and how clinicians currently make decisions) and how you design competition to work. But the impact is plain – European healthcare systems are already benefiting significantly from the introduction of biosimilar competition.
Until this analysis, it may have been harder for policy makers to know that they are benefiting from biosimilars sparking competition today. It certainly remains a challenge for patients, clinicians and other stakeholders to understand the benefits of biosimilars. For them, savings are not their top concern necessarily, of course. Instead their questions are around the idea of biosimilarity, and indeed biological medicines, as many stakeholders haven't spent much time thinking about the science and regulation underpinning them (quite naturally). To address these points, NHS England coordinated a broad group of stakeholders, including industry, to help put together a short brochure on What is a Biosimilar to help bridge this challenge, what I would argue is the next translational gap for biosimilars. Biosimilars are here and they're making a difference.