Samsung Bioepis Launches PYZCHIVA® (ustekinumab-ttwe) Biosimilar in US

Incheon, Korea, February 24, 2025 – Samsung Bioepis Co., Ltd. has announced the launch of its new biosimilar drug, PYZCHIVA (ustekinumab-ttwe), in the United States. This medication is a biosimilar to Stelara (ustekinumab) and has received approval for treating several conditions, including moderate to severe plaque psoriasis in candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. Through its commercialization partner, Sandoz, PYZCHIVA is now available across the US in multiple forms: pre-filled syringes of 45 mg/0.5 mL and 90 mg/mL, a 130 mg/26 mL intravenous infusion single-dose vial, and 45 mg/0.5 mL subcutaneous vials.

Linda Y. MacDonald, the Executive Vice President and Head of Global Commercial Division at Samsung Bioepis, emphasized the importance of this launch for the company and the millions of patients in the US living with inflammatory conditions. She pointed out that the introduction of PYZCHIVA could help reduce healthcare costs and contribute to a more sustainable healthcare system. Samsung Bioepis remains committed to innovation and making medicine more accessible to those in need.

The commercialization agreement for PYZCHIVA between Samsung Bioepis and Sandoz was finalized in September 2023. Under this agreement, Samsung Bioepis will handle the development, registration, intellectual property, manufacturing, and supply of the drug. The license period for PYZCHIVA in the US began on February 22, 2025, as outlined in the settlement and license agreement between Samsung Bioepis and Janssen Biotech Inc.

Samsung Bioepis boasts a diverse portfolio of 11 biosimilars in various stages of development and approval, spanning therapeutic areas such as immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Currently, the company has ten biosimilars approved in the US, with five already commercially available.

PYZCHIVA (ustekinumab-ttwe) is designed for both subcutaneous and intravenous use. It has specific indications and safety information that prescribers must be aware of. The drug is contraindicated in patients with significant hypersensitivity to ustekinumab products or any excipients in PYZCHIVA.

Healthcare providers should consider several warnings and precautions associated with PYZCHIVA. The drug may elevate the risk of infections, including serious bacterial, mycobacterial, fungal, and viral infections. Patients with any active infection should not begin treatment with PYZCHIVA until the infection has resolved. Additionally, individuals genetically predisposed to IL-12/IL-23 deficiencies may be more vulnerable to certain infections.

Before starting PYZCHIVA, patients should be evaluated for tuberculosis, and treatment should be initiated for latent tuberculosis if necessary. Continued monitoring for active tuberculosis signs is recommended during and after treatment with PYZCHIVA. Malignancies, including non-melanoma skin cancers, have been observed in patients taking ustekinumab products, necessitating careful monitoring.

Hypersensitivity reactions, including anaphylaxis, are possible with PYZCHIVA. If such reactions occur, treatment should be discontinued immediately. There have been reports of posterior reversible encephalopathy syndrome (PRES) in patients using ustekinumab products, requiring vigilant monitoring for associated symptoms.

Vaccination guidelines stipulate that patients receive all recommended immunizations before starting PYZCHIVA, avoiding live vaccines during and after treatment. The drug has also been linked to noninfectious pneumonia in post-approval monitoring, requiring attention to respiratory symptoms.

In conclusion, Samsung Bioepis' introduction of PYZCHIVA in the US represents a significant advancement in treatment options for patients with inflammatory diseases. The company continues to drive healthcare innovation, aiming to improve accessibility and affordability for patients worldwide.