In an effort to combat competition from biosimilar adalimumab products in Europe as patents covering the reference product expired last month, AbbVie, developer of Humira, is reportedly prepared to offer a substantial discount. However, many European nations have policies that require a mandatory reduction of the reference product’s list price after biosimilar entry.
In an effort to combat new competition from biosimilar adalimumab products in Europe as patents covering the reference product expired last month, AbbVie, developer of the reference product, Humira, is reportedly prepared to offer a substantial discount.
AbbVie, whose adalimumab has never before faced biosimilar competition, seems to be preparing to protect its market share as 4 new biosimilar adalimumab products, Imraldi, Hyrimoz, Amgevita, and Hulio entered the European market last month.
This week, multiple news outlets, including FiercePharma, have reported that, according to analyst Ronny Gal, AbbVie won a European national tender for adalimumab by dropping its price by 80%.
If true, such a price cut could be an effort to match biosimilar prices. AbbVie's CEO, Rick Gonzalez, noted last week, as reported by Regulatory Focus, that biosimilar versions were available at discounts ranging from 10%-80%. “The discounting has been on the higher end,” acknowledged Gonzalez.
However, The Center for Biosimilars® was unable to independently confirm the claim that AbbVie reduced its own prices by 80% and subsequently won a national tender. While the Danish national tendering authority’s Dorthe Bartels, MSc, acknowledged in October during the DIA Biosimilars Conference in London, United Kingdom, that the tender would be decided shortly and implemented in mid November, the Danish national authority has told The Center for Biosimilars® in an email that it cannot discuss the results of the tender agreement until November 15.
Notably, however, as described by Moorkens, et al, in a paper in Plos One, many European nations have policies that require a mandatory reduction of the reference product’s list price after biosimilar entry.1
For example, in Austria, after a third biosimilar has begun to be reimbursed, the reference product is required to match the price of the cheapest of the 3 biosimilars. If it is the case that at least 3 of the 4 EU-launched biosimilars have been made available in this territory, and if 1 has been made available at an 80% discount, an 80% price cut to Humira on AbbVie’s part would simply be in keeping with public policy.
In Finland, after any biosimilar is launched, the price paid for the originator is renegotiated. In Iceland, the price of a biosimilar cannot exceed the lowest wholesale price paid in any of 4 countries—Denmark, Norway, Sweden, and Finland—and the price of the reference is automatically reduced when a biosimilar enters the market.
Even as the details of this rumored tender deal remain unconfirmed, the eventual US adalimumab biosimilar market continues to progress. Earlier this week, the FDA approved adalimumab biosimilar Hyrimoz, bringing the total number of approved biosimilar adalimumab products to 3 in the United States, though none will enter the market before 2023 in compliance with individual deals AbbVie has entered into with biosimilar developers.
1. Moorkens E, Vulto AG, Huys I, et al. Policies for biosimilar uptake in Europe: an overview. Plos One. 2017;12(12):e0190147. doi: 10.1371/journal.pone.0190147.