Mylan Launches Hulio in the European Union

On Friday, Mylan announced that it has launched its biosimilar adalimumab, Hulio, in the European Union. Hulio’s entrance into the marketplace brings the number of available biosimilar adalimumab therapies to 4.

Hulio, approved for all indications of the reference Humira, was authorized by the European Commission in September 2018.

Mylan’s president, Rajiv Malik, said in a statement, "We're proud of our strategic partnership with Fujifilm Kyowa Kirin Biologics and the strong collaboration of our science and technology teams to bring Hulio to market for patients. As the cost of healthcare continues to rise around the world, we know the important role that biosimilars play to ensure patients can access the medicines they need. The availability of Hulio, the fourth product in the area of complex generics and biosimilars that Mylan is bringing to market in Europe, will positively impact the lives of patients in Europe suffering from chronic diseases such as autoimmune disorders."

The product, which was developed by Mylan’s partner Fujifilm Kyowa Kirin Biologics, received a positive opinion from the European Medicines Agency in July 2018.

The companies’ clinical package was supported by data from a phase 3 study of the biosimilar in patients with rheumatoid arthritis (RA). In the double-blind study, patients with active RA that was not adequately controlled with methotrexate were randomized 1:1 to receive 40 mg of either the biosimilar or the reference Humira every other week with concomitant methotrexate.

At week 24, 72.5% of the patients taking Hulio had met American College of Rheumatology criteria for 20% improvement (ACR20), while 74.3% of the reference group had also achieved ACR20. Safety profiles and the prevalence of antidrug antibodies (ADA) were also comparable.In the trial’s open-label extension, patients either continued to receive the biosimilar or the reference adalimumab, or switched from their first treatment to the other. ACR20 response rates were comparable after continuous and switched treatments, and no consistent differences in pharmacokinetics or ADA profiles were observed between continuous or switched treatment groups.

Hulio joins Sandoz’s Hyrimoz, Samsung Bioepis’ Imraldi, and Amgen’s Amgevita in the European marketplace.