Samsung Bioepis said on the 14th that the prefilled pen formulation of its autoimmune disease treatment "Epyztek" received product approval from the Ministery of Food and Drug Safety. Epyztek is a Stelara biosimilar developed by global drugmaker Janssen. Stelara generates about 15 trillion won in annual sales.
Samsung Bioepis plans to launch the prefilled pen formulation in the first half. The pen formulation allows patients to administer the drug easily and accurately. Earlier, Epyztek was released in Korea in 2024 as a prefilled syringe formulation.
Samsung Bioepis sells Epyztek in Europe and the United States through partner Sandoz under the name "Pyzchiva." It holds a 35% share in the European Stelara biosimilar market. A company official said, "The Ministery of Food and Drug Safety approval is the first pen formulation approval in Korea," adding, "We will expand treatment access."