Pyzchiva® (ustekinumab-ttwe) received the FDA’s approval as a biosimilar to Stelara®, partners Samsung Bioepis and Sandoz announced on July 1.
The approval applies to the full set of autoimmune indications of the reference product. In addition, Pyzchiva was given “provisional” approval as an interchangeable product, which means that it cannot be used as such until the marketing exclusivity of a previously approved agent (Wezlana®) expires.
Sandoz’s Chief Scientific Officer, Claire D’Abreu-Hayling, said in a press statement: “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.”
Sandoz will commercialize the product in North America and Europe, under an agreement signed in September 2023. Samsung Bioepis is responsible for manufacturing and supply. Sandoz indicated that it will launch Pyzchiva in February 2025, based on a settlement between Samsung Bioepis and the reference manufacturer. The launch timeline for the ustekinumab biosimilars will be very tight, with up to six launches possible before the end of 2025’s second quarter.
