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.
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.
Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva in the US, Canada, the European Economic Area (EEA), Switzerland, and the UK. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply.
