Samsung Bioepis Receives Domestic Product Approval for Epysatek Pen Formulation

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[Financial News] Samsung Bioepis announced on the 14th that it has received approval from the Ministry of Food and Drug Safety for the prefilled pen formulation (PFP) of 'Epiztec', a biosimilar of Stelara (ingredient name: ustekinumab).
\r\nThis product approval marks the first case in Korea where a ustekinumab-based drug has been developed and approved in a pen formulation. Unlike the existing product form, the prefilled injection formulation (PFS), the pen formulation is designed to allow patients to administer the drug more easily and accurately, increasing convenience in self-administration environments.
Epiztec is a biosimilar of Stelara, a treatment for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis developed by Janssen. Stelara has a mechanism of inhibiting the activity of interleukin (IL)-12 and 23, and its annual global sales amount to approximately 15 trillion won.
Samsung Bioepis launched Epiztec in Korea in 2024 at a price about 40% lower than the original drug. The pen formulation that was recently approved is scheduled to be launched in the first half of this year.
\r\nIn addition, Samsung Bioepis is selling Stelara biosimilar Fiztiva (Epiztec's US and European product name) through its partner Sandoz in Europe and the US, and is recording the largest market share (35%) in the biosimilar market in Europe.
Currently, Samsung Bioepis has received approval for the first pen formulation in Korea and is preparing to launch the pen formulation in the first half of the year.
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vrdw88@fnnews.com Kang Jung-mo Reporter