FDA approves biosimilar Pyzchiva for all approved Stelara indications



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Key takeaways:

  • Pyzchiva, an ustekinumab biosimilar, is approved for all indications of the reference medicine, including psoriatic arthritis.
  • The drug is expected to be available in the United States in February.

The FDA has approved the Stelara biosimilar Pyzchiva for psoriatic arthritis, Crohn’s disease and all other indications approved for the reference medicine, according to a press release from Sandoz.

Pyzchiva (ustekinumab-ttwe; Samsung Bioepis, Sandoz) is slated to debut on the U.S. marketplace in February, according to the release. The Stelara (ustekinumab, Janssen) biosimilar, which has received interchangeable designation, was developed by Samsung Bioepis and licensed for marketing by Sandoz.



Image: Healio

The FDA has approved Pyzchiva, a biosimilar of ustekinumab, for PsA, Crohn’s disease and all other indications approved for the reference medicine.

The drug will be available in 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection, as well as a 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion.

Leah M. Howard

“Systemic medications like biologics are a key treatment option for many people to manage symptoms of psoriasis and psoriatic arthritis,” Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation, said in the release. “Unfortunately, barriers to care, including costs, often prevent patients from getting the drug they are prescribed. Psoriatic disease is lifelong and chronic, leading to long-term treatment costs. Having more FDA-approved options can help make appropriate health care more affordable.”

Indications for ustekinumab-ttwe include moderate-to-severe plaque psoriasis, active PsA, moderately to actively severe Crohn’s disease and moderately to actively severe ulcerative colitis in adults. The drug is also approved for pediatric patients with moderate-to-severe plaque psoriasis and active PsA.

Claire DAbreu-Hayling

“This approval reflects our dedication to ensuring high-quality treatments are universally accessible,” Claire D’Abreu-Hayling, chief scientific officer at Sandoz, said in the release. “By further expanding our immunology portfolio with affordable biosimilar alternatives, we continue to make significant strides towards achieving our goal of delivering life-changing medicines to the patients who need them.”

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