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

Mark C Genovese,Rafael Muniz,Yasumasa Arai,Herbert Kellner,Rieke Alten

doi:10.1136/rmdopen-2019-000987

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

Mark C Genovese, Rafael Muniz + Show 3 more

Open Access

https://doi.org/10.1136/rmdopen-2019-000987

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Journal: RMD Open	Publication Date: Apr 1, 2020
Citations: 17	License type: open-access

Affiliation: Stanford Medicine, Mylan (United States), Kyowa Kirin (Japan), Fujifilm (Japan), München Klinik, Medical School Berlin

#Open-label Extension Studies #Long-term Efficacy + Show 8 more

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Abstract

Background/ObjectiveFKB327 is a biosimilar of the antitumour necrosis factor adalimumab reference product (RP). A randomised, double-blind (DB) phase 3 study compared the efficacy of FKB327 with the RP in patients...

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