FKB327

01/01/2020 - "A randomised, double-blind (DB) phase 3 study compared the efficacy of FKB327 with the RP in patients with active rheumatoid arthritis (RA) inadequately controlled with methotrexate (MTX). "
01/01/2020 - "Long-term safety, immunogenicity and efficacy comparing FKB327 with the adalimumab reference product in patients with active rheumatoid arthritis: data from randomised double-blind and open-label extension studies."
11/01/2020 - "Immunogenicity of an adalimumab biosimilar, FKB327, and its reference product in patients with rheumatoid arthritis."
12/12/2019 - "To compare the efficacy, serum drug concentrations, immunogenicity, and safety of FKB327 with the adalimumab reference product (RP) in combination with methotrexate in patients with moderate-to-severe, active rheumatoid arthritis (RA). "
02/01/2019 - "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. "

06/19/2020 - "Since 2017, five biosimilars of adalimumab were approved by the European Medicines Agency [EMA] for use in inflammatory bowel disease: ABP 510, SB5, GP2017, FKB327, and MSB11022. "
01/01/2022 - "The adalimumab biosimilars FKB327 and GP2017 were approved for the therapy of patients with inflammatory bowel disease (IBD). "

01/01/2021 - "The US Food and Drug Administration and/or the European Medicines Agency have approved eight biosimilars of adalimumab (ABP 501/BI 695501/SB5/GP2017/FKB327/MSB11022/PF-06410293/CT-P17) for the treatment of psoriasis, and others are under review. "

01/01/2020 - "FKB327 is a biosimilar of the antitumour necrosis factor adalimumab reference product (RP). "

01/01/2022 - "Adalimumab biosimilars FKB327 (Hulio®) and GP2017 (Hyrimoz®) were indicated to 50 naive patients in terms of biological therapy with Crohn's disease (CD) or ulcerative colitis (UC). "