Samsung Bioepis launches Stelara biosimilar in US to expand treatment options

Samsung Bioepis said that Pyzchiva, a biosimilar referencing Stelara (ingredient: ustekinumab), is now available in the U.S.

Through its commercialization partner Sandoz, Samsung Bioepis has made Pyzchiv available in the U.S. in various formulations, including 45 mg/0.5 mL and 90 mg/mL pre-filled syringes, a 130 mg/26 mL intravenous infusion single-dose vial, and a 45 mg/0.5 mL subcutaneous vial.

Samsung Bioepis and Sandoz signed a commercialization agreement for Pyzchiva in September 2023 for the U.S. market. While Samsung Bioepis oversees the development, registration, intellectual property, manufacturing, and supply, the license period for Pyzchiva in the U.S. commenced on Feb. 22, 2025, under a settlement and license agreement with Janssen Biotech.

The drug has received approval for treating moderate to severe plaque psoriasis in patients eligible for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis.

“The launch of Pyzchiva marks a significant milestone for Samsung Bioepis and millions of patients in the U.S. living with inflammatory conditions,” Samsung Bioepis Executive Vice President and Head of Global Commercial Division Linda Y. MacDonald said. “Expanding treatment options can help reduce healthcare costs and contribute to a more sustainable healthcare system.”

Samsung Bioepis remains committed to improving patient access through continuous innovation, MacDonald said.

Samsung Bioepis currently has 11 biosimilars in its portfolio, spanning immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. The company has secured approval for 10 biosimilars in the U.S., with five already commercially available.