JULY 3, 2024

FDA Approves Pyzchiva Biosimilar to Stelara

The FDA approved ustekinumab-ttwe (Pyzchiva, Sandoz), a biosimilar to Stelara (Janssen). 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 it is currently subject to an unexpired period of