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Sandoz Group AG S/ADR (SDZNY) is a global leader in generic and biosimilar medicines, providing affordable and high-quality treatments to patients worldwide. With a diverse portfolio of over 1500 products, Sandoz addresses a wide range of diseases from the common cold to cancer. Their recent achievements include the launch of new biosimilar products like Pyzchiva® and the expansion of production facilities to meet growing demand.
The FDA has approved Pyzchiva® (ustekinumab-ttwe), a biosimilar developed by Samsung Bioepis, for all indications of its reference medicine, Stelara®. Pyzchiva® is set to be commercialized by Sandoz in the US starting February 2025, following a settlement with Janssen Biotech. This biosimilar will be available in various forms, including pre-filled syringes and vials for subcutaneous and intravenous administration. FDA's provisional determination also makes Pyzchiva® interchangeable with Stelara®. This approval is a significant milestone for Sandoz, enhancing its immunology portfolio and market position. The medication is approved for treating multiple conditions including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The approval is based on robust clinical studies demonstrating equivalent efficacy and safety compared to its reference medicine.
Sandoz has secured European Commission approval for Wyost® and Jubbonti®, the first biosimilars of denosumab in Europe. Wyost® is approved for cancer-related bone disease, while Jubbonti® is for osteoporosis. These approvals, based on a robust development program, mark a significant growth milestone for Sandoz.
Wyost® and Jubbonti® will launch in November 2025. The approvals aim to increase access to essential treatments and align with Sandoz's strategy to provide sustainable healthcare solutions. Cancer and osteoporosis are significant health burdens, with cancer-related bone diseases affecting many patients and osteoporosis increasing fracture risks in the aging population.
Sandoz reported strong first quarter 2024 sales with net sales of USD 2.5 billion, up 6% in constant currencies. Biosimilar business grew by 21%, all regions contributed to growth. Acquisition of CIMERLI® completed in March 2024. Generics sales remained steady. Full-year net sales guidance of mid-single digits in constant currencies.
Sandoz Group AG shareholders approved all proposals by the Board of Directors at the Annual General Meeting. Gilbert Ghostine was re-elected as Chairman, with Mathai Mammen, Graeme Pitkethly, and Michael Rechsteiner joining as new Board members. A dividend of CHF 0.45 per share was approved. The AGM also re-elected auditors and the independent proxy.
Sandoz has reached an agreement with Amgen to resolve all patent litigation related to its US denosumab biosimilars, allowing for the launch of Jubbonti® and Wyost® on May 31, 2025, or earlier under certain conditions. These biosimilars are the first and only FDA-approved alternatives to Prolia® and Xgeva®. The settlement strengthens Sandoz's biosimilar portfolio and growth strategy.
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