Sandoz, a key player in generic and biosimilar medicines, announced that the European Commission (EC) has granted marketing authorization for Pyzchiva (biosimilar ustekinumab), developed and registered by Samsung Bioepis.
According to the company’s statement, 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.
Rebecca Guntern, President Sandoz Europe, said: “Chronic inflammatory diseases affect millions of people around the world and can have a profoundly negative impact on their quality of life. This approval is a crucial step towards offering European patients an additional safe and effective treatment option and further demonstrates our commitment to pioneer access to potentially life-changing medicines.”
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 company announced.
In September 2023, Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis. 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.
