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

Front Immunol. 2021 Apr 6:12:638444. doi: 10.3389/fimmu.2021.638444. eCollection 2021.

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.

Keywords: adalimumab; biosimilar; efficacy; immunogenicity; rheumatoid arthritis; safety; tumor necrosis factor-α.

Publication types

  • Review

MeSH terms

  • Adalimumab / therapeutic use*
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / drug therapy*
  • Biosimilar Pharmaceuticals / therapeutic use*
  • Clinical Trials as Topic
  • Humans

Substances

  • ABP 501
  • Antirheumatic Agents
  • BI 695501
  • Biosimilar Pharmaceuticals
  • GP2017
  • PF-06410293
  • Adalimumab