‘Totality of Evidence’ Approach in the Development of GP2017, an Approved Adalimumab Biosimilar
Norman Gaylis,
Charlotte Both,
Lena Lemke
et al.
Abstract:Introduction
Hyrimoz
®
, (GP2017 [SDZ-ADL]), is a biosimilar to Humira
®
(REF-ADL). SDZ-ADL was approved in 2018 by both the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) for the indications of REF-ADL not protected by orphan exclusivity. In 2023, the US FDA and EMA also approved a citrate-free high-concentration formulation (HCF) of SDZ-ADL.
Totality of Evidence—the approach
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