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

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.