Samsung Bioepis has announced US Food and Drug Administration (FDA) approval for PYZCHIVA (ustekinumab-ttwe / SB17) as a biosimilar to Stelara (ustekinumab).
The approval includes subcutaneous injections of 45 mg/0.5 mL and 90 mg/mL, and an intravenous 130 mg/26 mL solution of the product.
PYZCHIVA is indicated for multiple conditions including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis.
The US regulator granted a provisional determination for PYZCHIVA’s interchangeability designation.
The approval is based on comprehensive evidence confirming its biosimilarity to Stelara.
This includes analytical, non-clinical and clinical data that show no significant differences in safety, purity and potency.
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A Phase I clinical trial demonstrated pharmacokinetic equivalence and comparable safety and immunogenicity profiles between PYZCHIVA and Stelara in healthy volunteers.
Further clinical evidence from a Phase III trial involving patients with moderate to severe plaque psoriasis supported the biosimilarity of SB17 to Stelara.
The study showed equivalent efficacy and comparable safety and pharmacokinetic profiles up to week 28.
The Phase III study also confirmed the biosimilarity of SB17 to Stelara in terms of efficacy, safety, pharmacokinetics and immunogenicity up to week 28.
Samsung Bioepis vice-president and regulatory affairs team leader Byoung In Jung stated: “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.
“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.”
Samsung Bioepis’s PYZCHIVA will be commercialised by Sandoz in the US.
In September 2023, the companies signed a commercialisation agreement for SB17 covering the US, Europe, Canada, Switzerland and the UK.
According to the settlement and licence agreement between Samsung Bioepis and Janssen Biotech, the licence period for PYZCHIVA in the US will commence on 22 February 2025.
