Biosimilar adalimumab FKB327 (Hulio®)
Milan Lukáš Orcid.org 1
+ Affiliation
The text is available only in Czech.
To read this article in full, please register for free on this website.
Benefits for subscribers
Benefits for logged users
Literature
1. Slíva J. Originální nebo biosimilární adalimumab? Acta Medicinae 2019; 1: 88–89.
2. Puri A, Niewiarowski A, Arai Y al. Pharmacokinetics, safety, tolerability and immunogenicity of FKB327 a new biosimilar medicine of adalimumab/Humira, in healthy subjects. Br J Clin Pharmacol 2017; 83 (7): 1405–1415. doi: 10.1111/bcp.13245.
3. Genovese MC, Glover J, Matsunga N et al. Efficacy, safety and immunogenicity in randomized, double blind (DB) and open-label extension (OLE) studies comparing FKB327, an adamimumab biosimilar, with the adalimumab reference product (Humira®; RP) in patients (pts) with active rheumatoid arthritis. Athritis Rheumatol 2017; 69 (Suppl 10) : 2799.
4. Souhrn údajů o přípravku. [online]. Dostupné z: http: / / www.ema.europa.eu.