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

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.