Samsung Bioepis Co. has signed a settlement and license settlement with Johnson & Johnson regarding the commercialization of PYZCHIVA, a biosimilar to Stelarai (ustekinumab), in Europe. The phrases of the settlement stay confidential.
Ustekinumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that stops irregular regulation of IL-12 and IL-23 related to immune-mediated ailments. PYZCHIVA, developed by Samsung Bioepis, was accepted as a biosimilar to Stelara (ustekinumab) by the European Fee (EC) in April 2024. PYZCHIVA is presently accepted for the remedy of adults and paediatric sufferers from the age of 6 years and older with average to extreme plaque psoriasis, adults with lively psoriatic arthritis, adults with average to severely lively Crohn’s illness.
“It is a important milestone for sufferers dwelling with autoimmune ailments as we’re making a step ahead in bettering entry to this essential biologic medication for healthcare methods, suppliers, and sufferers,” stated Linda Choi MacDonald, govt vice chairman and international head of business, Samsung Bioepis. “With unwavering dedication to high quality, we are going to proceed our efforts to make our medicines extra accessible in order that extra sufferers can obtain the remedy they want.”
PYZCHIVA was launched by Sandoz in Europe in July 2024. PYZCHIVA grew to become accessible in pre-filled pen (autoinjector) in Could 2025.
