On April 4, AbbVie announced a patent settlement with biosimilar manufacturer Samsung Bioepsis, delaying the launch of Humira (adalimumab) biosimilar, Imraldi, to June 2023 in the US.
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 this year. GlobalData believes that Humira biosimilars may not have as fast an uptake as Remicade biosimilars in the EU, especially for gastroenterology indications.
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Key opinion leaders (KOLs) interviewed by GlobalData have indicated that 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.
Despite these limitations, GlobalData believes that Humira biosimilars will have significant uptake in the EU since they are anticipated to be priced 10-20% lower than the originator brand across the EU. This will be further facilitated by the quotas that healthcare authorities have in place for biosimilar prescription. One of the highest quotas are from UK’s National Health Service (NHS), which 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 hence could be lower. An analysis of GlobalData’s survey of high-prescribing physicians indicates that on an average, gastroenterologists treating UC anticipate prescribing the biosimilar versions to around 45% of the total adalimumab-treated population in the 5EU by 2021.
In addition to the launches of Imraldi and Amgevita this year, Boehringer Ingelheim’s adalimumab biosimilar, Cyltezo, is slated to launch in the EU within the next year as well. Furthermore, in the wake of the recent AbbVie settlement, other biosimilar developers have been encouraged to advance their commercialization efforts in the EU. 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 (EMA), with a decision anticipated in H2 2018.
Related Reports
GlobalData (2017). PharmaPoint: Crohn’s Disease – Global Drug Forecast and Market Analysis to 2026, September 2017, GDHC160PIDR
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By GlobalDataGlobalData (2017). PharmaPoint: Ulcerative Colitis – Global Drug Forecast and Market Analysis to 2025, January 2017, GDHC142PIDR
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