Adv Ther. 2025 Mar;42(3):1360-1392. doi: 10.1007/s12325-024-03098-z.Epub 2025 Feb 5.

Piotr Wiland ¹, Charlotte Both ², Norman B Gaylis ³, Russell D Cohen ⁴, Jonas Halfvarson ⁵, Lena Lemke ², Oliver von Richter ², Andrew Blauvelt ^6 7

Author information

¹Department of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland.

²HEXAL AG (a Sandoz Company), Holzkirchen, Germany.

³Arthritis and Rheumatic Disease Specialties, Aventura, FL, USA.

⁴Department of Medicine, Section of Gastroenterology, University of Chicago, Chicago, IL, USA.

⁵Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.

⁶Oregon Medical Research Center, Portland, OR, USA. blauveltconsults@gmail.com.

⁷Blauvelt Consulting, LLC, Portland, OR, USA. blauveltconsults@gmail.com.

Abstract

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.