GlobalData Reports on Humira Biosimilars Uptake in EU

On May 4, 2018, GlobalData, a data and analytics company, reported that Humira (adalimumab)‎‎ biosimilars will have significant uptake in the European Union (EU) when they are launched in 2018 because they are anticipated to be priced 10–20% lower than the originator brand across the EU. Humira is AbbVie’s top-selling drug with $18.4 billion in 2017 sales.

Biosimilar uptake in the EU will be further facilitated by the quotas that healthcare authorities have in place for biosimilar prescription, according to GlobalData. The United Kingdom’s National Health Service (NHS) has one of the highest quotas because the NHS recommends that 90% of new patients and 80% of patients currently receiving therapy be prescribed the lower-cost biologic (or biosimilar) within 12 months of the launch of a biosimilar.

“Actual uptake does vary among different hospitals and healthcare facilities and could in fact be lower. On average, gastroenterologists treating ulcerative colitis, anticipate prescribing the biosimilar versions to around 45% of the total adalimumab-treated population in the 5EU [France, Germany, Italy, Spain, and UK] by 2021,” said Lakshmi Dharmarajan, PhD, GlobalData associate director of Immunology, in a company press release.

On April 4, AbbVie announced a patent settlement with biosimilar manufacturer Samsung Bioepsis, delaying the launch of Imraldi, a Humira biosimilar, to June 2023 in the United States. The company struck a similar deal with Amgen last year, pushing Amgevita’s US launch to January 2023. However, AbbVie has given its permission for the companies to launch the biosimilars in Europe starting in October 2018.
“We believe that Humira biosimilars may not have as fast an uptake as Remicade biosimilars in the EU, especially for gastroenterology indications,” said Dharmarajan in the company press release.

According to key opinion leaders interviewed by GlobalData, the use of adalimumab biosimilars over the branded drug would be influenced more by individual physicians than is the case for infliximab biosimilars, where hospitals play a major role in decision making. This is especially true for ulcerative colitis (UC), where most of the patients treated with adalimumab are outpatients, while infliximab is used more in the hospital setting.

In addition to the launches of Biogen and Samsung Bioepsis’ Imraldi and Amgen’s Amgevita this year, Boehringer Ingelheim’s adalimumab biosimilar, Cyltezo, is set to launch in the EU within the next year as well. Following the recent AbbVie settlement, other biosimilar developers have been encouraged to advance their commercialization efforts in the EU, according to GlobalData.

“One example of this is the recent agreement between Fujifilm and Mylan, in which Mylan was granted an exclusive license to commercialize Fujifilm’s adalimumab biosimilar in the European market. The biosimilar is currently awaiting approval from the European Medicines Agency, with a decision anticipated in H2 2018,” Dharmarajan said in the press release.

Source: GlobalData