European Commission approval of Pyzchiva (ustekinumab biosimilar), further strengthening immunology offering
Sandoz, announces 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.
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.