Mylan Launches Biosimilar Adalimumab, Hulio, in Spain

This week, Mylan launched its biosimilar adalimumab, Hulio, in Spain. The biosimilar, referencing Humira, was developed by Mylan’s partner, Fujifilm Kyowa Kirin Biologics, and received European authorization in September 2018.

Christophe Maupas, MD, director general of Mylan Spain, said in a statement that the biosimilar is expected to have a favorable impact on the sustainability of the Spanish healthcare system, where there are an estimated 300,000 patients with rheumatoid arthritis (RA), and between 84,000 and 120,000 patients with inflammatory bowel disease.

Maupas also touted the biosimilar’s device design, saying that its retractable needle and plastic syringe body—which reduce the risk of accidental puncture and the risk of breakage, respectively—offer important benefits to the patient.

The biosimilar has also demonstrated what investigators called a “significant advantage” over the reference drug in terms of injection-site pain; in data presented at The European League Against Rheumatism European Congress of Rheumatology 2019, researchers said that, in data polled from 4 studies of the biosimilar in more than 1000 patients, injection with the biosimilar resulted in a 12.6-point lower pain score than the reference on the visual analog scale.

The biosimilar, which is already available in other European Markets, such as the United Kingdom, gained its EU approval on the basis of data from a phase 3 study in patients with 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 (ADAs) 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.