EC Gives Nod to Ustekinumab Biosimilar
The European Commission (EC) has granted marketing authorization for Pyzchiva, a ustekinumab biosimilar developed and registered by Samsung Bioepis. Pyzchiva is approved as a biologic therapy within gastroenterology, dermatology, and rheumatology. The comprehensive regulatory submission package included extensive analytical, preclinical, and clinical data, including a Phase I PK/PD study and a Phase III confirmatory study. […]