Two studies recently reported on Hulio, the adalimumab biosimilar marketed and developed by Mylan and its partner Fujifilm Kyowa Kirin Biologics.
Two studies recently reported on the adalimumab biosimilar marketed and developed by Mylan and its partner Fujifilm Kyowa Kirin Biologics, saying Hulio (named FKB327 during development) is equivalent to AbbVie’s blockbuster adalimumab (Humira) for treating rheumatoid arthritis, as well as having comparable bioavailability among delivery methods.
Adalimumab, an inhibitor of tumor necrosis factor alpha (TNF-ɑ), is typically prescribed for rheumatoid arthritis and additional conditions including psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
A randomized, phase 3, double-blind study of 24-week duration (Period I) followed by an open-label period (Period II) found FKB327 was equivalent to reference product Humira in clinical efficacy and demonstrated comparable safety and immunogenicity in patients with moderate-to-severe rheumatoid arthritis also taking methotrexate.1
FKB327 contains adalimumab but includes different excipients. Preclinical studies showed FKB327 and originator adalimumab are comparable with respect to binding to the target antigens and for inducing apoptosis and cellular cytotoxicity. A subsequent phase 1 clinical study of FKB327 and adalimumab demonstrated comparable pharmacokinetic, safety, and immunogenicity profiles.
The primary endpoint of Period I was ACR20 (American College of Rheumatology) response rate. At 24 weeks of treatment, 74.1% of patients on FKB327 and 75.7% of patients on adalimumab showed an ACR20 response. ACR50 and ACR70 response rates were also similar in the 2 groups.
During the open-label phase of the study (Period II), patients were re-randomized, with two-thirds remaining on the same treatment and the other third switching treatments. No significant differences in ACR20, ACR50, ACR70 response rates were seen between the 4 drug sequence groups at 54 weeks or at interim points throughout Periods I and II. Immunogenicity and rates of adverse events were also comparable between groups.
The second trial was an open-label study which assessed bioavailability of a single subcutaneous dose of FKB327 in 195 healthy subjects by 3 different delivery methods: prefilled syringe, auto-injector, and vial with disposable syringe. This study reported pharmacokinetic parameters, safety, immunogenicity were similar in the 3 delivery methods, suggesting these delivery methods could be used interchangeably in clinical practice.2
In 2018, Humira accounted for 61% of AbbVie’s revenues, but that percentage began falling last year as adalimumab competitors in Europe, such as Hulio, took hold. In the United States, however, Humira will not face a biosimilar challenger until 2023.
1. Genovese MC, Glover J, Greenwald M, et al. FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension [published online December 12, 2019]. Arthritis Res Ther. doi:10.1186/s13075-019-2046-0
2. Bush J, Kawakami K, Muniz R. A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects [published online December 30, 2019]. BMC Pharmacol Toxicol. doi:10.1186/s40360-019-0376-9.