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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
Department of Rheumatology and Internal Medicine, Medical University, Wroclaw, Poland.
HEXAL AG (a Sandoz Company), Holzkirchen, Germany.
Arthritis and Rheumatic Disease Specialties, Aventura, FL, USA.
Department of Medicine, Section of Gastroenterology, University of Chicago, Chicago, IL, USA.
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2025 (English)In: Advances in Therapy, ISSN 0741-238X, E-ISSN 1865-8652, Vol. 42, no 3, p. 1360-1392Article, review/survey (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Springer, 2025. Vol. 42, no 3, p. 1360-1392
Keywords [en]
Adalimumab, Arthritis, Biosimilar, GP2017, Hyrimoz, Inflammatory bowel disease, Psoriasis, Sandoz-adalimumab, Spondyloarthritis
National Category
Pharmacology and Toxicology
Identifiers
URN: urn:nbn:se:oru:diva-119118DOI: 10.1007/s12325-024-03098-zISI: 001415209600001PubMedID: 39907897Scopus ID: 2-s2.0-85217692419OAI: oai:DiVA.org:oru-119118DiVA, id: diva2:1935126
Note

Funding Agency:

Sandoz

Correction to: Efficacy, Safety, and Immunogenicity of SDZ-ADL, an Adalimumab Biosimilar, in Biologic-Naïve and Switched Patients with Immune-Mediated Inflammatory Diseases: A Literature Review. Wiland, P., Both, C., Gaylis, N.B. et al.  Adv Ther (2025). https://doi.org/10.1007/s12325-025-03181-z

Available from: 2025-02-06 Created: 2025-02-06 Last updated: 2025-04-29Bibliographically approved

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