Samsung Bioepis Receives Domestic Approval for Epzutek Pen Formulation

Improved Convenience... Expanding Treatment Options

Samsung Bioepis announced on January 14 that it has received product approval from the Ministry of Food and Drug Safety for the pre-filled pen (PFP) formulation of its autoimmune disease treatment, Epzutek (ingredient: ustekinumab).

Incheon Yeonsu-gu Samsung Bioepis Building. Samsung Bioepis

This approval marks the first case in Korea where a pen-type formulation of a ustekinumab-based drug, including the original product, has been developed and authorized by the Ministry of Food and Drug Safety, as opposed to the conventional pre-filled syringe (PFS) format. The pen formulation is designed to allow patients to administer the medication more easily and accurately, offering advantages in terms of convenience for self-injection.

Epzutek is a biosimilar to Stelara. Stelara, developed by Janssen, is a treatment for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, with annual global sales reaching approximately 15 trillion won (10.361 billion dollars).

Jung Byungin, Head of the Regulatory Affairs Team at Samsung Bioepis, stated, "This approval by the Ministry of Food and Drug Safety is a meaningful achievement, as it is the first pen-type formulation approved in Korea that practically enhances patient convenience. We will continue to expand treatment accessibility through ongoing patient-centered formulation innovations."

Samsung Bioepis plans to launch the Epzutek pen formulation in the first half of this year.