Posted by Michael Wonder on 25 May 2023
Sandoz marketing authorisation applications for proposed biosimilar denosumab accepted by EMA
25 May 2023 - Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and the integrated Phase I/III ROSALIA clinical trial.
Sandoz today announced that the EMA has accepted the marketing authorisation applications for proposed biosimilar denosumab for regulatory review.
