Sandoz + Samsung Bioepis' Pyzchiva,(ustekinumab-ttwe), a biosimilar to Stelara, has gained FDA approval.
Sandoz, the global leader in generic and biosimilar medicines, announced that the FDA has approved biosimilar Pyzchiva (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/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 US. 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.
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