FDA Approves Pyzchiva, a Biosimilar to Stelara
Sandoz has announced that the U.S. Food and Drug Administration (FDA) approved biosimilar Pyzchiva®* (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection and 130mg/26mL (5mg/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.
- Pyzchiva® is approved by the FDA for all indications of the reference medicine
Stelara®† (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist including to treat adult
patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis, as well as pediatric patients with moderate to severe plaque psoriasis and active psoriatic arthritis. - 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.
- *Pyzchiva® is a trademark of Samsung Bioepis Co. Ltd.† Stelara® is a registered trademark of JOHNSON & JOHNSON (USA).
