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Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis

Xiaoqin Lu, Rui Hu, Lin Peng, Mengsi Liu, Zhen Sun

2021Frontiers in Immunology65 citationsDOIOpen Access PDF

Abstract

Adalimumab, as a TNF inhibitor biologic for the treatment of rheumatoid arthritis, is one of the top-selling drugs worldwide. As its various patents have gradually expired, experiments on its biosimilars are constantly being implemented. In this review, we summarized clinical trials of seven biosimilars currently approved by the FDA and/or EMA for the treatment of rheumatoid arthritis, namely: ABP 501 (Amjevita/Amgevita/Solymbic), BI 695501 (Cyltezo), SB5 (Imraldi/Hadlima), GP2017 (Hyrimoz/Hefiya/Halimatoz), MSB11022 (Idacio), FKB327 (Hulio), and PF-06410293 (Abrilada). Overall, these biosimilars showed similar efficacy, safety, and immunogenicity to adalimumab. All biosimilar switching trials indicated that switching from adalimumab to a biosimilar does not have a significant impact on efficacy, safety, and immunogenicity.

Topics & Concepts

BiosimilarAdalimumabMedicineRheumatoid arthritisImmunogenicityClinical trialSafety profilePharmacologyAdverse effectInternal medicineImmunologyImmune systemBiosimilars and Bioanalytical MethodsTuberculosis Research and EpidemiologyRheumatoid Arthritis Research and Therapies