FDA Approves Samsung Bioepis' PYZCHIVA as Stelara Biosimilar

Samsung Bioepis has received approval from the US Food and Drug Administration (FDA) for PYZCHIVA (ustekinumab-ttwe / SB17), a biosimilar to Stelara (ustekinumab). The approved product formulations include subcutaneous injections of 45 mg/0.5 mL and 90 mg/mL, along with an intravenous solution of 130 mg/26 mL. PYZCHIVA is intended for the treatment of several conditions: moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn’s disease and ulcerative colitis.

This FDA approval is based on a thorough assessment of data demonstrating the biosimilarity of PYZCHIVA to Stelara. Multiple forms of evidence were considered, including analytical, non-clinical, and clinical data. The evidence indicated no significant differences in safety, purity, or potency between PYZCHIVA and Stelara.

A pivotal Phase I clinical trial provided initial confirmation of the pharmacokinetic equivalence and comparable safety and immunogenicity profiles between PYZCHIVA and Stelara in healthy volunteers. Further validation came from a Phase III clinical trial conducted on patients with moderate to severe plaque psoriasis. The Phase III study substantiated the equivalent efficacy, safety, and pharmacokinetic profiles of SB17 compared to Stelara, with these results being consistent up to week 28.

Byoung In Jung, the vice-president and regulatory affairs team leader at Samsung Bioepis, highlighted the significance of the FDA approval for patients with inflammatory conditions. He noted that biosimilars such as PYZCHIVA could expand treatment options and improve access to biologic therapies. Moreover, biosimilars hold the potential to alleviate the financial pressures on healthcare systems, particularly in the US, where biologics represent a substantial portion of annual drug spending.

PYZCHIVA will be commercialized in the US by Sandoz. In September 2023, Samsung Bioepis and Sandoz entered into a commercialization agreement covering the US, Europe, Canada, Switzerland, and the UK. Under the terms of a settlement and license agreement between Samsung Bioepis and Janssen Biotech, the licensing period for PYZCHIVA in the US will start on February 22, 2025.

This milestone underscores the growing importance of biosimilars in modern healthcare, offering not only more treatment choices but also the potential for cost savings. The approval of PYZCHIVA is a step forward in providing effective, safe, and more accessible therapeutic options for patients dealing with chronic inflammatory diseases.