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<p>Sandoz-adalimumab (SDZ-ADL; Hyrimoz<sup>®</sup>, GP2017) is an adalimumab (ADL) biosimilar approved for the treatment of immune-mediated inflammatory diseases. Here, we review the available literature on SDZ-ADL from controlled and real-world evidence studies. A literature search was carried out to identify articles published up to July 2023 reporting data on efficacy, safety, immunogenicity, and treatment retention rates for SDZ-ADL. In randomized clinical trials, the efficacy, safety, and immunogenicity of SDZ-ADL were comparable to those observed for reference-adalimumab (ref-ADL) and not altered after single or multiple drug switches. Real-world studies confirmed the effectiveness and safety of treatment initiation with SDZ-ADL and of switching to SDZ-ADL from ref-ADL or from other ADL biosimilars. This literature review provides evidence that SDZ-ADL is as effective and safe as ref-ADL in both biologic-naïve and biologic-experienced patients.</p>

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Efficacy, Safety, and Immunogenicity of SDZ-ADL, an Adalimumab Biosimilar, in Biologic-Naïve and Switched Patients with Immune-Mediated Inflammatory Diseases: A Literature Review

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年2月5日

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  • Piotr Wiland,
  • Charlotte Both,
  • Norman B. Gaylis,
  • Russell D. Cohen,
  • Jonas Halfvarson,
  • Lena Lemke,
  • Oliver von Richter,
  • Andrew Blauvelt

摘要

Sandoz-adalimumab (SDZ-ADL; Hyrimoz®, GP2017) is an adalimumab (ADL) biosimilar approved for the treatment of immune-mediated inflammatory diseases. Here, we review the available literature on SDZ-ADL from controlled and real-world evidence studies. A literature search was carried out to identify articles published up to July 2023 reporting data on efficacy, safety, immunogenicity, and treatment retention rates for SDZ-ADL. In randomized clinical trials, the efficacy, safety, and immunogenicity of SDZ-ADL were comparable to those observed for reference-adalimumab (ref-ADL) and not altered after single or multiple drug switches. Real-world studies confirmed the effectiveness and safety of treatment initiation with SDZ-ADL and of switching to SDZ-ADL from ref-ADL or from other ADL biosimilars. This literature review provides evidence that SDZ-ADL is as effective and safe as ref-ADL in both biologic-naïve and biologic-experienced patients.