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JULY 16, 2024

FDA Approves Pyzchiva Biosimilar to Stelara


Originally published by our sister publication Pharmacy Practice News

The FDA approved ustekinumab-ttwe (Pyzchiva, Sandoz), a biosimilar to Stelara. Pyzchiva will be available in 45 mg/0.5 mL and 90 mg/mL prefilled syringes for subcutaneous injection and a 130 mg/26 mL (5 mg/mL) single-dose vial for IV infusion.

Ustekinumab-ttwe was approved for all indications of its reference biologic; the FDA provisionally determined that ustekinumab-ttwe would be interchangeable with the reference product as