Hyrimoz® (GP2017 [SDZ-ADL]) is a biosimilar to reference adalimumab (Humira® [REF-ADL]) and was approved in 2018 by both the United States Food and Drug Administration and European Medicines Agency based on the Totality of Evidence.

Comprehensive comparative analytical and functional assessments demonstrated that SDZ-ADL was analytically indistinguishable from REF-ADL, and confirmatory clinical studies established the clinical similarity between the two medicines in healthy volunteers and patients with immune-mediated disorders.

A citrate-free high-concentration formulation of SDZ-ADL (HCF-SDZ-ADL) was also approved in 2023 in the US and Europe.

Comparable pharmacokinetics and matching safety and immunogenicity between HCF-SDZ-ADL and SDZ-ADL were confirmed within a Phase I bridging study.