‘Totality of Evidence’ Approach in the Development of GP2017, an Approved Adalimumab Biosimilar

ConclusionOverall, the Totality of Evidence provided for biosimilar adalimumab, SDZ-ADL, confirmed the analytical, functional and clinical similarity of SDZ-ADL to REF-ADL, supporting its regulatory approval and providing a data bridge with which to evaluate and support the approval of citrate-free HCF SDZ-ADL for clinical use.
Source: Advances in Therapy - Category: Drugs & Pharmacology Source Type: research