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

CONCLUSION: Overall, 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.PMID:38514505 | DOI:10.1007/s12325-024-02809-w

Source: Adv Data - March 22, 2024 Category: Epidemiology Authors: Norman Gaylis Charlotte Both Lena Lemke Oliver von Richter Paul Yamauchi Source Type: research