Pharma Focus Asia

FDA Approves Samsung Bioepis' PYZCHIVA® (ustekinumab-ttwe), a Biosimilar to STELARA®

Monday, July 01, 2024

Samsung Bioepis Co., Ltd. has received U.S. FDA approval for PYZCHIVA® (ustekinumab-ttwe), a biosimilar to Stelara (ustekinumab). This approval covers subcutaneous and intravenous administration for treating moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis. PYZCHIVA has also been granted provisional interchangeability.

Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, said, “The FDA approval of PYZCHIVA as a biosimilar to Stelara is a significant milestone for patients with inflammatory conditions. Biosimilars offer more treatment options and can reduce healthcare costs, especially in the US, where biologics make up a large portion of drug spending. We are committed to expanding access to medicines by advancing our biosimilar pipeline.”

The FDA’s decision was based on extensive evidence including analytical, non-clinical, and clinical data showing no meaningful differences in safety, purity, and potency compared to Stelara. Phase 1 and Phase 3 clinical studies demonstrated PYZCHIVA’s pharmacokinetic equivalence, safety, tolerability, immunogenicity, and efficacy. These results were published in the Journal of the American Academy of Dermatology and presented at the 2024 American Academy of Dermatology Annual Meeting.

Samsung Bioepis has partnered with Sandoz to commercialize PYZCHIVA in the United States starting February 22, 2025. The agreement also includes Canada, the European Economic Area (EEA), Switzerland, and the United Kingdom. Samsung Bioepis’ portfolio includes 11 biosimilars across various therapeutic areas, with seven approved in the US and four commercially available as of June 2024.

PYZCHIVA is available for subcutaneous (45 mg/0.5 mL and 90 mg/mL) and intravenous (130 mg/26 mL solution) administration. It is indicated for:

Contraindications: PYZCHIVA is contraindicated in patients with significant hypersensitivity to ustekinumab products or any of its excipients.



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