Sandoz announces FDA approval of biosimilar Pyzchiva

Sandoz (SDZNY) announced that the FDA 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, 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 U.S. in February 2025, in accordance with the settlement and license agreement with Janssen Biotech (JNJ) previously announced by Samsung Bioepis. Pyzchiva is expected to be among the first wave of ustekinumab biosimilars to launch in the U.S.