EU approves fifth Humira biosimilar with Mylan, Fujifilm's Hulio

Mylan and Fujifilm Kyowa Kirin Biologics announced Thursday that the European Commission granted marketing authorisation for Hulio, a biosimilar referencing AbbVie's Humira (adalimumab), for all indications. The decision marks the EU's fifth approval to date of a biosimilar to Humira, which generated sales of $18.4 billion in 2017. Mylan and Fujifilm plan to launch Hulio in Europe on or after October 16. 

The approval follows a positive opinion adopted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use in July. Fujifilm's submission seeking approval of the biosimilar, also known as FKB327, was accepted for review by the EMA last year. 

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Mylan entered into a partnership in April to jointly commercialise Hulio with Fujifilm in Europe. Mylan president Rajiv Malik remarked "we've made great progress with Fujifilm…and look forward to continuing this important collaboration." 

The other Humira biosimilars approved in Europe are Amgen's Amgevita, Samsung Bioepis' Imraldi, Boehringer Ingelheim's Cyltezo, and most recently Hyrimoz from Novartis' Sandoz unit.

Mylan reached an agreement with AbbVie earlier this year regarding its proposed biosimilar referencing Humira. Under the deal, Mylan will receive a non-exclusive license for Humira in the US that will begin on July 31, 2023. AbbVie has also reached agreements settling Humira biosimilar disputes with Amgen, as well as with Biogen and partner Samsung Bioepis.

For related analysis, see ViewPoints: AbbVie concedes biosimilar defeat in Europe by shoring up its US Humira empire. See also ViewPoints: AbbVie stakes out post-Humira path with Orilissa.

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