Samsung Bioepis Gets FDA Approval for Biosimilar of J&J’s Stelara

Published: Jul 01, 2024 By Tyler Patchen

Samsung/iStock, JHVEPhoto

Pictured: Exterior of a Samsung location in San Jose, California/iStock, JHVEPhoto

Samsung Bioepis announced Monday that the FDA has approved Pyzchiva (ustekinumab—ttwe), a biosimilar of Johnson & Johnson’s blockbuster immunotherapy Stelara.

Pyzchiva is approved to treat severe plaque psoriasis patients who are candidates for systemic therapy or phototherapy. The biosimilar is also indicated for active psoriatic arthritis, moderately to severely active Crohn’s disease, as well as moderately to severely active ulcerative colitis. Pyzchiva has also been granted a provisional determination for interchangeability and will be commercialized by Sandoz in the U.S.

“The FDA approval of Pyzchiva as a biosimilar to Stelara is an important milestone for patients living with inflammatory conditions, as biosimilars can offer more choice and access to biologic treatments,” Byoung In Jung, vice president and…
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