Battle Over Humira Begins in Europe as 5-Year Wait Begins in US

Regulatory NewsRegulatory News | 22 October 2018 |  By 

The world’s best-selling biologic, AbbVie’s Humira (adalimumab), is now facing competition in Europe from at least four companies, although the US will have to wait until 2023 for competition.

The discrepancies between the US and EU markets for adalimumab biosimilars has been largely chalked up to the legal constraints and additional patents that AbbVie has protecting its most lucrative asset into the 2030s. But the difference of five years in the US, for insurers and the federal government, will likely cost billions of dollars.

The deals between AbbVie and competitors (outlined below), mean that Humira, which was first approved by FDA in 2002 and has accumulated sales of more than $100 billion in its first 15 years by treating a range of diseases from rheumatoid arthritis to plaque psoriasis to inflammatory bowel disease, will be on the US market for more than 20 years with no competition.
Competitor US Launch Date Launched in EU? Name of biosimilar
Amgen 31 January 2023 Yes - Amgevita
Samsung Bioepis 30 June 2023 Yes - Imraldi
Mylan 31 July 2023 Yes - Hulio
Novartis’ Sandoz 30 September 2023 Yes - Hyrimoz
Fresenius Kabi 30 September 2023 Can launch upon approval
Boehringer Ingelheim Approved in US as Cyltezo (adalimumab-adbm), no launch date yet Approved in EU, has yet to launch


© 2023 Regulatory Affairs Professionals Society.

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