Biosimilar Boon for Europe’s Payers as Humira Price Falls

November 18, 2018 | Drug

Melanie senior

AbbVie is being hit harder than expected by the October 2018 arrival in Europe of biosimilar versions of Humira (adalimumab). Europe’s payers were better prepared than ever to take full advantage of the competition, helping push the price of this top-selling drug down by 80% in some markets. With at least four copies already launched and more to follow, AbbVie leadership was forced to concede, during an early November investor call, that they had under-estimated European sales erosion. Current estimates are now a 26-27% drop-off in 2019, resulting from more aggressive discounts. Just how aggressive isn’t clear. In a call with Credit Suisse analysts in early November 2018, AbbVie management was tight-lipped on whether it had gone to 80% or not, or which countries –if any- it has walked away from. Still, CS lowered their target price for AbbVie shares, underscoring the extent of the risk to the company.

The adalimumab launches show that Europe’s biosimilars market has come of age. The challenge for biosimilar companies is no longer primarily to educate physicians and payers about what biosimilars are; it is now about differentiating their own version from the competitors, and trying to ensure price falls do not become unsustainable.

Adalimumab caught the headlines because of its size. But it won’t be the last biosimilar: Europe’s payers are already lining up to take advantage of copies of Amgen’s neutropenia drug Neulasta (pegfilgrastim), three of which have already received European Medicines Agency approval. If the uptake of biosimilar filgrastim (Neupogen) is anything to go by, 2019 could be a painful year for Neulasta sales – though Amgevita, Amgen’s biosimilar adalimumab, may help compensate. Amgevita was the first of the Humira copycats to be approved and among the first to launch on October 16, 2018.

Europe’s payers are united in their hunger for savings, but each differs in the measures and tools used to drive uptake. Some countries run nation-wide, single winner tenders where price is everything. Others prefer multi-winner tenders, taking into account local provider preferences for factors such as product presentation, stability/shelf-life, and consistency of supply. Biosimilars Market Access in the EU, a Datamonitor report, outlines country-by-country biosimilar dynamics, including data on the penetration of approved biosimilars in individual markets. The report explains the many variables that influence biosimilar success across Europe, providing recommendations on how to address regulatory, legal and commercial challenges in each region. It also provides background on naming and labelling issues across Europe, and explains Europe’s evolving intellectual property landscape and the IP issues associated with the class.

Understanding the national and regional nuances across Europe’s biosimilar markets is critical to commercial success in biosimilars, as the category matures and as competition heats up. Future launches are likely to be faster, with more aggressive price-cuts.

Over a decade since the launch of Europe’s first biosimilar, Sandoz’s Omnitrope (somatropin), Europe’s payers and patients now have experience across a range of biosimilars, from relatively simple molecules like growth hormone or erythropoietin to the more complex monoclonal antibodies like infliximab or adalimumab.

And as real-world data accumulates around biosimilar use and switching across different therapy areas, the full impact of this category is becoming clearer. Biosimilars are not simply forcing down prices. They are also beginning to influence treatment pathways in some markets, as providers begin to use more widely-available biologics earlier than payer budgets would previously allow.

This is a category to watch.