Mylan, Fujifilm Receive EU Approval for Biosimilar of AbbVie’s Humira

The European Commission (EC) has granted marketing authorization for Hulio (adalimumab), a biosimilar to AbbVie’s Humira (adalimumab), an anti-inflammatory drug, for all indications, to Mylan and Fujifilm Kyowa Kirin Biologics Co., a biosimilars company formed from Fujifilm. Humira is AbbVie’s top-selling drug with 2017 sales of $18.43 billion.

The EC approval of Hulio applies to all 28 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein. Mylan plans to launch Hulio across various markets in Europe on or after October 16, 2018.

Mylan and Fujifilm Kyowa Kirin Biologics partnered earlier this year (2018). Fujifilm Kyowa Kirin Biologics has a nonexclusive royalty-bearing license with AbbVie (Mylan has a sublicense) for the use and sale of Hulio in European countries. Humira had brand sales of approximately $4.4 billion in Europe for the 12 months ending June 30, 2018, according to IQVIA, and as reported by Mylan.

In July 2018, AbbVie signed patent license agreements with Mylan over Mylan’s proposed biosimilar to AbbVie’s Humira. Under the agreements, AbbVie granted Mylan a non-exclusive license on specified dates to AbbVie’s intellectual property relating to Humira in the US and in various other countries around the world in which AbbVie has intellectual property, excluding Europe. Mylan’s US license will begin on July 31, 2023, and will not be accelerated by the entry of other Humira biosimilars, including Amgen’s or Samsung Bioepis’ biosimilar. Mylan will pay royalties to AbbVie for licensing its Humira patents once its biosimilar product is launched.

Hulio is indicated for the same indications of Humira, including: rheumatoid arthritis; ankylosing spondylitis; axial spondyloarthritis without radiographic evidence of ankylosing spondylitis; psoriatic arthritis; psoriasis; hidradenitis suppurativa; Crohn’s disease; ulcerative colitis; uveitis; polyarticular juvenile idiopathic arthritis (age 2 and older); enthesitis-related arthritis (age 6 and older); plaque psoriasis (age 4 and older); Crohn’s disease (age 6 and older); hidradenitis suppurativa (age 12 and older); uveitis (age 2 and older)

Source: Mylan

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