In just a few years, the biosimilar sales in the US will outpace those in the EU, according to a consultant speaking at ACI’s 11th Summit on Biosimilars and Innovator Biologics last week. This will be likely driven by a single biosimilar, and you can probably guess which one.
The EU is not a monolithic pharmaceutical market, but rather many different markets operating independently of each other, beyond their unified regulatory process. This means that biosimilar uptake varies across Europe not only by biosimilar but by country. For example, the Nordic countries have the greatest uptake of biosimilars, not the least because of their single national tenders. The result is winner-take-all bidding wars, according to Aurelio Arias, Engagement Manager, European Thought Leadership, IQVIA.
A likely further result is a race to provide the greatest discounts possible, which could be a hindrance to the long-term viability of the market, stated Mr. Arias. On the other hand, the acceptance by a country of multiple tenders “does not necessarily affect the speed of biosimilar uptake, but it does allow for healthy competition.” In this scenario, the winner tends to get 60% of the market, he commented, with 40% shared by the other tender winners. In single-tender markets, biosimilar makers may become frustrated and decide against bidding for them, thinking they cannot win the national tender outright, he said.
The EU–US Biosimilar Match Race
In terms of biosimilar uptake, the US is still towards the back of the pack of Western countries, noted Mr. Arias. “The comparison is not apples to apples,” he said, “because the US has been let down by slow infliximab biosimilar uptake.” Even with Europe’s greater uptake of biosimilars, it still only represents 1% of all biologics prescribed in the EU. In terms of global revenues, according to Mr. Arias, “Europe has been leading the market for biosimilars, but the US will become the leader when the Humira® biosimilars are launched in 2023,” owing to the magnitude of adalimumab sales ($15 billion) in the US.
He pointed out that although uptake rates are generally more rapid in countries using national tenders, the US and Canada are ahead of Europe in terms of bevacizumab uptake. For EU countries not using national tenders, speed of biosimilar uptake has demonstrated a consistent pattern: 40% biosimilar marketshare in year 1 and 60% in year 2. The US has seen 40% uptake in year 1 for bevacizumab, he affirmed. “We can no longer characterize biosimilar uptake in the US as sluggish,” Mr. Arias asserted. Furthermore, the biosimilar approval rate by the US Food and Drug Administration now equals that of the European Medicines Agency.
“The rate of uptake is largely up to the company behind the biosimilar launch,” he said. However, it does pay to be first to market. In the EU, Amjevita® was first to market, and Amgen has led in uptake in most EU countries.
What about non-US, non-EU markets? They account for only $1.0 billion in biosimilar sales in 2020, compared with $15.0 billion globally. And the gap will likely widen in the next few years. The companies focused on non-US, non-EU markets may be discouraged by the large clinical trials needed for approval in the West, Mr. Arias said. Certainly, the current focus by manufacturers on blockbuster targets will ensure US/EU dominance in biosimilar sales for years to come. He pointed to two blockbusters as examples of lucrative upcoming biosimilar targets: Simponi® has $11 billion in global sales and patent expiration in 2024-2025. NovoLog® registers $12 billion in sales with a patent expiration of 2020-2021.
Does Biosimilar Utilization Yield Greater Patient Access?
One of the arguments in favor of quickly ramping up biosimilar uptake is that the savings gained will fund access to biologics for a larger number of patients. That’s the premise, anyway. Mr. Arias and his IQVIA colleagues wonder if this can be proven.
Even in Europe’s 15-year-old biosimilar market, commented Mr. Arias, patient access is not easy to measure. “We can measure volume changes in prescriptions after the biosimilar enters a market, but the results are inconclusive. To date, we’ve only seen increases in prescriptions for infliximab and glargine in Europe, but even these have been only moderate increases.”
In the US, prior authorization and step therapy programs are often employed by commercial payers to prevent first-line use of costly biologics. In other words, they seek to ensure that patients try other less-expensive treatments first before accessing biologics. Unless payers adjust their policies to encourage the use of biosimilars (by perhaps not requiring prior authorization for its use), evidence of greater patient access will be fleeting, at least on the commercial side.