FKB327: An Adalimumab Biosimilar
- 60 Downloads
FKB327 (Hulio®) is a biosimilar of the reference monoclonal anti-TNFα antibody adalimumab, and is approved in the EU for use in the same indications as reference adalimumab. FKB327 has similar physicochemical and pharmacodynamic properties to those of reference adalimumab, and pharmacokinetic equivalence was shown in healthy volunteers and patients with moderate-to-severe rheumatoid arthritis (RA) despite methotrexate therapy. FKB327 demonstrated equivalent clinical efficacy to that of reference adalimumab in patients with moderate-to-severe RA, and similar tolerability, safety and immunogenicity profiles. Switching from reference adalimumab to FKB327 had no impact on efficacy, safety or immunogenicity.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of FKB327 was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit. Zaina T. Al-Salama is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
- 1.European Medicines Agency. Hulio (adalimumab): summary of product characteristics. 2018. https://www.ema.europa.eu/. Accessed 7 Jan 2019.
- 2.European Medicines Agency. Assessmemnt report: Hulio (international non-propriatary name: adalimumab). 2018. https://www.ema.europa.eu/. Accessed 7 Jan 2019.
- 4.Alten R, Glover J, Matsunaga N, et al. Efficacy and safety results of a phase III study comparing FKB327, an adalimumab biosimilar, with the adalimumab reference product in patients with active rheumatoid arthritis [abstract no. OP0021]. Ann Rheum Dis. 2017;76(Suppl 2):59.Google Scholar
- 5.Genovese MC, Glover J, Matsunaga N, et al. Efficacy, safety and immunogenicity in randomized, double-blind (DB) and open-label extension (OLE) studies comparing FKB327, an adalimumab biosimilar, with the adalimumab reference product (Humira; RP) in patients (PTS) with active rheumatoid arthritis (RA) [abstract no. 2799]. Arthritis Rheumatol. 2017;69(Suppl 10):111.Google Scholar