European Commission Authorizes Mylan and Fujifilm's Adalimumab Biosimilar, Hulio

Today, Mylan and its partner Fujifilm Kyowa Kirin Biologics announced that the European Commission has granted marketing authorization to Hulio, the partnerships’ adalimumab biosimilar referencing Humira. The biosimilar received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for the molecule, FKB327, in July 2018.

The authorization applies to all 28 EU member states, as well as the European Economic Area states, for all indications of the reference Humira.

Read more about Hulio.

Mylan President Rajiv Malik commented, “We’re very pleased with the decision of the European Commission to grant marketing authorization for Hulio. This is the fourth product that Mylan will be bringing to market in the area of complex generics and biosimilars, and we’re proud to be a leader in the market formation. We’ve made great progress with Fujifilm Kyowa Kirin Biologics and look forward to continuing this important collaboration.”

The partnership says that it will launch the drug on or after October 16, 2018; in a statement, the companies revealed that Fujifilm Kyowa Kirin has obtained a nonexclusive royalty license with Humira maker, AbbVie, for the use and sale of adalimumab in Europe, and that Mylan has a sublicense. Mylan has previously announced a settlement with AbbVie that covered only Mylan’s right to market a biosimilar adalimumab in ex-European territories, including the United States, starting in July 2023.

Hulio will join a widening group of adalimumab biosimilars entering the European marketplace next month; Samsung Bioepis and Biogen stuck a deal with AbbVie in April 2018 that will allow them to launch their Imraldi on October 16, and Amgen reached a similar settlement in 2017 that will allow it to enter the market on the same date as Imraldi.

Health systems in Europe are already preparing to introduce biosimilar adalimumab and reap what they hope will be a substantial cost savings; the United Kingdom’s National Health Service, for one, has implemented a working group to provide oversight on using the best-value adalimumab using a commissioning framework that launched in 2017. The framework proposes that at least 90% of patients new to treatment and 80% of patients currently receiving treatment be prescribed the best-value biologic within 12 months of the launch of a biosimilar for a given biologic therapy.