US biosimilars five years on: Life on Mars?

One year ago, I wrote about the need for more competition to “get the towels off the deckchairs” and “open up the beach” for biosimilar competition in the US.

A lot has happened since then. Most importantly, we are still in the middle of an unprecedented pandemic that has at least temporarily crippled the economy in the US and beyond, over and above the immediate impact on people’s lives and well-being.

Paradoxically, while Covid-19 has heightened political focus on the need for essential medicines, it has also made it temporarily harder to launch new products, including biosimilars, with the potential to get more patients diagnosed and treated while helping to make healthcare budgets more sustainable.

We have seen this also at Sandoz with initial uptake for our latest US biosimilar slowed by factors including the Covid-19 lockdown. However, the picture looks very different for the first-ever US biosimilar (also from Sandoz), which this week celebrates the fifth anniversary of its US launch and has already overtaken the reference medicine in terms of market share.

A rising tide lifts all boats

Looking beyond our company, I’m pleased to see that the competition is now also making good progress, particularly in oncology biosimilars, where the market is now beginning to take off just as I and others predicted. A rising tide lifts all boats, so I look forward to this trend continuing, both in oncology and in other critical areas including immunology and insulins. But there’s still a way to go – it’s no coincidence that the US remains roughly a decade behind Europe when it comes to biosimilar progress, with barely a quarter of global biosimilar sales despite accounting for well over half of the total worldwide biologics market. There are many reasons for this gap, including differences in the US and European legal and regulatory framework. We talk a lot about measures to drive biosimilar penetration, but the first step to success in any market is being able to enter it in the first place... Of course, we can’t blame it all on the lawyers! Some of the delays in the US have been due to regulatory challenges, with several biosimilar companies including Sandoz receiving adverse FDA feedback on their submissions. However, this is the sort of challenge that will always face pioneers in any field.

Venus and Mars?

Even a year ago, any realistic comparison of the European and US market environments would have had to conclude that, in many ways, this is “Venus and Mars”. In addition to the differing legal and regulatory landscapes, there are also enormous differences in market structure (with the US system often offering financial incentives that lead players to choose the most expensive option, due to “price-plus” reimbursement policies or volume-based rebate systems that favor established players).

There’s also the perennial problem of biosimilar misinformation, which contributes to slower uptake in the US. This ranges from materials that directly or indirectly challenge the safety of biosimilars to more subtle approaches, for instance the implication – with no basis in either science or regulatory policy – that a “non-interchangeable biosimilar” may not offer identical quality levels. (Note that biosimilar interchangeability is itself a US-specific regulatory phenomenon, with no equivalent in Europe or elsewhere).

Several key players, including the FDA, have launched good initiatives to fight this misinformation, but there is still a lot of work to be done to ensure that US patients, healthcare professionals and other stakeholders understand the true value of biosimilars.

Of course, we saw this also in the early days of biosimilars in Europe, but the Europeans have benefited since from the best possible antidote to such misinformation: well over a decade of positive market experience.

As already mentioned, the last year has seen positive new launch uptake for several oncology biosimilars, comparable to initial experience in Europe. While it’s still too early to conclude that the US biosimilar market is set for sustainable success, I’m increasingly confident that it will eventually deliver on expectations. After all, we have been here before in other industries, with the US overtaking the early entrants. (Think telecommunications and digital).

It will take patience (and perseverance!) to fully open up the market for US biosimilars, but the early signs are that this apparently hostile landscape really does have everything it takes to sustain “Life on Mars”.