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<p>The introduction of biosimilars into global markets has increased utilisation and reduced costs of biological therapies. However, the uptake varies by country because of differences in biosimilar knowledge and concerns about their safety and efficacy. This review examines clinical and real-world data on the effects of switching between reference and biosimilar (SDZ-ETN, SB4, LBEC0101, YLB113) etanercept on treatment efficacy and safety in patients with inflammatory rheumatic and musculoskeletal diseases. To date, all controlled clinical trials and real-world studies indicate that switching between reference and biosimilar etanercept does not affect treatment efficacy and safety. These findings support broader biosimilar adoption to improve patient access and reduce healthcare costs. However, published data on multiple biosimilar switches and patient-reported outcomes remain limited, warranting further research efforts in these areas.</p>

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Clinical and Real-World Evidence on Etanercept Biosimilar Switching: A Narrative Literature Review of Efficacy and Safety

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年11月18日

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  • Marc Schmalzing,
  • Ayman Askari,
  • Giampiero Girolomoni,
  • Julio C. V. Perez-Coleman,
  • Cristofer Salvati,
  • Elena Bachinskaya

摘要

The introduction of biosimilars into global markets has increased utilisation and reduced costs of biological therapies. However, the uptake varies by country because of differences in biosimilar knowledge and concerns about their safety and efficacy. This review examines clinical and real-world data on the effects of switching between reference and biosimilar (SDZ-ETN, SB4, LBEC0101, YLB113) etanercept on treatment efficacy and safety in patients with inflammatory rheumatic and musculoskeletal diseases. To date, all controlled clinical trials and real-world studies indicate that switching between reference and biosimilar etanercept does not affect treatment efficacy and safety. These findings support broader biosimilar adoption to improve patient access and reduce healthcare costs. However, published data on multiple biosimilar switches and patient-reported outcomes remain limited, warranting further research efforts in these areas.