Samsung Bioepis Reaches Settlement Agreement for PYZCHIVA® (ustekinumab) in Europe

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Johnson & Johnson concerning the commercialization of PYZCHIVA^®, a biosimilar to Stelara (ustekinumab)¹, in Europe. The terms of the agreement remain confidential.

Ustekinumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that prevents abnormal regulation of IL-12 and IL-23 associated with immune-mediated diseases. PYZCHIVA, developed by Samsung Bioepis, was approved as a biosimilar to Stelara (ustekinumab) by the European Commission (EC) in April 2024. PYZCHIVA is currently approved for the treatment of adults and paediatric patients from the age of 6 years and older with moderate to severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderate to severely active Crohn’s disease.

“This is a significant milestone for patients living with autoimmune diseases as we are making a step forward in improving access to this important biologic medicine for healthcare systems, providers, and patients,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, Samsung Bioepis. “With unwavering commitment to quality, we will continue our efforts to make our medicines more accessible so that more patients can receive the treatment they need.”

PYZCHIVA was launched by Sandoz in Europe in July 2024. PYZCHIVA became available in pre-filled pen (autoinjector) in May 2025.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.

^1 Stelara is a trademark of Johnson & Johnson.