Biosimilar adalimumab FKB327 (Hulio®)

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https://doi.org/10.14735/amgh2019177
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References

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.