The U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Samsung Bioepis’ PYZCHIVA (ustekinumab-ttwe) subcutaneous injection and intravenous infusion as a biosimilar to Johnson & Johnson’s immunotherapy Stelara (ustekinumab).

PYZCHIVA has been approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. Additionally, a provisional determination was granted for PYZCHIVA’s interchangeability.

“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,” said Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “In addition, biosimilars have a potential to reduce the financial burden of healthcare systems, especially in the US where biologics account for more than 46% of the annual drug spending. We will continue to reinforce our commitment to widen access to medicines by advancing our biosimilar pipeline for the benefits of patients, healthcare providers, and healthcare systems around the world,” she added.

The FDA’s approval of PYZCHIVA is based on a totality of evidence including analytical, non-clinical and clinical data demonstrating biosimilarity to Stelara, with no clinically meaningful differences in terms of safety, purity and potency.

PYZCHIVA will be commercialized by Sandoz in the United States. Samsung Bioepis and Sandoz entered into a commercialization agreement for SB17 (PYZCHIVA) in September 2023 for the US, Canada, European Economic Area (EEA), Switzerland, and United Kingdom (UK). In the US, the license period for PYZCHIVA will begin on February 22, 2025, according to the settlement and license agreement between Samsung Bioepis and Janssen Biotech Inc.