The U.S. Food and Drug Administration has approved the biosimilar Pyzchiva (ustekinumab-ttwe) for treating moderate to severe plaque psoriasis in adult and pediatric patient aged 6 years and older who are candidates for phototherapy or systemic therapy, as well as active psoriatic arthritis. The treatment is also approved for adults and pediatric patients with moderately to severely active Crohn's disease and ulcerative colitis.

Pyszchiva is available for administration through subcutaneous injection, offered in dosages of 45 mg/0.5 mL and 90 mg/mL in pre-filled syringes. An alternative intravenous infusion form is also available, provided in a 130 mg/26 mL (5 mg/mL) single-dose vial.

Additionally, the FDA has provisionally determined that Pyzchiva may be interchangeable with its reference medicine, Stelara (ustekinumab). This decision was supported by robust clinical data, including a Phase 3 trial demonstrating therapeutic equivalence to Stelara in treating plaque psoriasis, and a Phase 1 study confirming bioequivalence in pharmacokinetics, safety, and immunogenicity.

Sandoz is scheduled to launch Pyzchiva by February 2025.