Real-world observational study of biosimilars in inflammatory arthritis treatment: a systematic literature review

Expert Opin Biol Ther. 2021 Jan;21(1):57-73. doi: 10.1080/14712598.2020.1812575. Epub 2020 Oct 16.

Abstract

Introduction: The use of biological agents in patients with rheumatic diseases has achieved the therapeutic target, i.e., remission or low disease activity. The share of biological agents has been growing with the approval of biosimilars, which have been recognized for their equivalent efficacy, safety, pharmacokinetics, and immunogenicity to the original as well as their reduced economic burden.

Area covered: Biosimilars are being examined for their bioequivalence to reference products in randomized-controlled trials; however, the use of biosimilars in actual clinical practice is complicated owing to issues with switching and comorbidities. Therefore, this review describes real-world data in the rapidly evolving field of biosimilars in the treatment of rheumatoid arthritis and spondyloarthropathy, including ankylosing spondylitis and psoriatic arthritis.

Expert opinion: According to published data, the use of biosimilars for inflammatory arthritis led to no significant inferiority in treatment outcomes and resulted in considerable cost savings in the real-world. Currently, beyond the use of biosimilars, issues with the interchangeability of biosimilars, including immunogenicity, should be addressed. Strategies to overcome these concerns will improve treatment efficacy and safety in patients with inflammatory arthritis.

Keywords: Biosimilar; arthritis; biologics; cost-effectiveness; observational study; switching.

Publication types

  • Research Support, Non-U.S. Gov't
  • Systematic Review

MeSH terms

  • Arthritis, Rheumatoid* / drug therapy
  • Biological Factors
  • Biosimilar Pharmaceuticals* / adverse effects
  • Humans
  • Observational Studies as Topic
  • Spondylitis, Ankylosing* / drug therapy
  • Therapeutic Equivalency

Substances

  • Biological Factors
  • Biosimilar Pharmaceuticals