Mylan and Fujifilm Kyowa Kirin Biologics have received authorisation from the European Commission (EC) to market Hulio, a biosimilar to AbbVie’s Humira (adalimumab).
Adalimumab is a selective inhibitor of tumour necrosis factor (TNF); TNF is known to cause inflammation in autoimmune disorders. The Humira biosimilar binds to TNF, blocks its activity and therefore reducing inflammation and other symptoms.
The EC clearance of Hulio covers all Humira indications. These include rheumatoid arthritis, ankylosing spondylitis, psoriasis, crohn’s disease, ulcerative colitis, uveitis and hidradenitis suppurativa in adults, as well as paediatric indications, such as polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, hidradenitis suppurativa and uveitis.
Fujifilm Kyowa Kirin Biologics president and CEO Dr Yoshifumi Torii said: “The EC’s approval of Hulio marks a significant milestone. In cooperating with Mylan, we continue to commit all efforts to bring high quality and affordable biosimilars to patients throughout European countries.”
AbbVie granted a non-exclusive royalty bearing licence to Fujifilm Kyowa Kirin Biologics for the use and sale of Hulio in European countries.
In July this year, Mylan signed similar patent licence agreements with AbbVie over rights for Humira biosimilar in the US and other relevant international markets, with the exception Europe.
Fujifilm Kyowa Kirin Biologics and Mylan initially partnered earlier this year. Mylan plans to launch Hulio across multiple European markets from mid-October this year.
Mylan Europe president Jacek Glinkasaid: “Biosimilars represent a huge opportunity in Europe to drive better patient access through high quality, value medications that support healthcare systems across the region to deliver ongoing excellent care in the face of aging populations and increasingly stretched resources.”
The clearance comes at a time when AbbVie is facing insurance-fraud charges in the US for allegedly offering illegal kickbacks to health-care providers in order to maintain Humira sales.