Sandoz, announced that the European Commission (EC) has granted marketing authorization for Pyzchiva® (biosimilar ustekinumab), developed and registered by Samsung Bioepis. Pyzchiva® is a key biosimilar value driver for the company over the mid-term and this approval is a major step in advancing Sandoz growth strategy. 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. 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. Pyzchiva® (ustekinumab) has been developed to match the reference medicine, a monoclonal antibody medication to interleukin (IL)-12/23 for the treatment of autoimmune disorders including within gastroenterology, dermatology, and rheumatology.