Sandoz announces FDA approves biosimilar Pyzchiva

Sandoz announced that the Food and Drug Administration has approved biosimilar Pyzchiva 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL single-dose vial for intravenous infusion. Developed by Samsung Bioepis Co., Ltd, it is approved for all indications of its reference medicine and will be commercialized by Sandoz in the U.S. In addition, the FDA provisionally determined that Pyzchiva would be interchangeable with the reference medicine as it is currently subject to an unexpired period of exclusivity for the first interchangeable biosimilar biological products. “Sandoz intends to launch Pyzchiva in the US in February 2025, in accordance with the settlement and license agreement with Janssen Biotech Inc. previously announced by Samsung Bioepis Co., Ltd. Pyzchiva is expected to be among the first wave of ustekinumab biosimilars to launch in the US. Pyzchiva is a key biosimilar value driver for the company over the mid-term, and this approval is a major step in advancing the Sandoz growth strategy by extending the US immunology portfolio,” the company stated. Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said: “This approval reflects our dedication to ensuring high-quality treatments are universally accessible. By further expanding our immunology portfolio with affordable biosimilar alternatives, we continue to make significant strides towards achieving our goal of delivering life-changing medicines to the patients who need them.”