FDA Approves PYZCHIVA®, Samsung Bioepis' Stelara Biosimilar

Samsung Bioepis Co., Ltd., based in Incheon, South Korea, has announced that the U.S. Food and Drug Administration (FDA) has approved their Biologics License Application (BLA) for PYZCHIVA® (ustekinumab-ttwe). This approval allows PYZCHIVA to be used as a biosimilar to Stelara® (ustekinumab), available both as a subcutaneous injection and an intravenous infusion. PYZCHIVA is intended for treating various inflammatory conditions, including moderate to severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Additionally, PYZCHIVA has received a provisional determination for interchangeability.

Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, highlighted the significance of this milestone, stressing that biosimilars like PYZCHIVA can provide patients with more treatment options and potentially reduce healthcare costs. Jung emphasized that biologics represent a significant portion of drug spending in the United States, and biosimilars can help alleviate this financial burden.

The FDA’s approval of PYZCHIVA was based on comprehensive evidence, including analytical, non-clinical, and clinical data that demonstrated the biosimilarity of PYZCHIVA to Stelara. Notably, results from a Phase 1 clinical study (NCT04772274) showed equivalent pharmacokinetics and comparable safety and tolerability profiles between PYZCHIVA and Stelara in healthy volunteers. A Phase 3 study (NCT04967508) involving patients with moderate to severe plaque psoriasis also supported PYZCHIVA’s biosimilarity to Stelara in terms of efficacy, safety, and pharmacokinetics up to 28 weeks.

Samsung Bioepis has entered into a commercialization agreement with Sandoz to market PYZCHIVA in the United States, Canada, European Economic Area (EEA), Switzerland, and the United Kingdom. In the U.S., the licensing period for PYZCHIVA will commence on February 22, 2025, as per an agreement with Janssen Biotech Inc.

PYZCHIVA is Samsung Bioepis’ seventh biosimilar and its fourth immunology biosimilar approved by the FDA. Samsung Bioepis has a robust portfolio of 11 biosimilars spanning immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. By June 2024, seven of these biosimilars were approved in the U.S., with four already commercially available.

The approved indications for PYZCHIVA include treatment for moderate to severe plaque psoriasis in patients 6 years and older, active psoriatic arthritis in the same age group, and moderately to severely active Crohn’s disease and ulcerative colitis in adults.

However, PYZCHIVA comes with certain safety warnings and precautions. It is contraindicated in patients with significant hypersensitivity to ustekinumab or its excipients. The drug may increase the risk of infections and reactivation of latent infections, with serious infections requiring hospitalization reported during clinical trials. Patients should be evaluated for tuberculosis before starting treatment with PYZCHIVA, and the drug should be discontinued if serious infections or clinically significant complications arise.

Patients on PYZCHIVA should avoid live vaccines due to the risk of infection transmission. Non-live vaccinations might not be fully effective during PYZCHIVA treatment. Additionally, there is a theoretical risk that patients could be more vulnerable to particular infections due to pharmacologic blockade of IL-12/IL-23.

Other serious adverse reactions include a potential increased risk of malignancy, hypersensitivity reactions like anaphylaxis, and noninfectious pneumonia. Monitoring for posterior reversible encephalopathy syndrome (PRES) and the appearance of non-melanoma skin cancer in high-risk patients is also advised.

Common adverse reactions reported include nasopharyngitis, upper respiratory tract infection, headache, fatigue, vomiting, and various infections at the injection site.

Samsung Bioepis remains committed to making healthcare accessible through the development of biosimilars, ensuring that patients, healthcare providers, and systems globally can benefit from these advancements.