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Samsung Bioepis Gains Approval to Enter Japanese Market with Autoimmune Biosimilar

Seoul: Samsung Bioepis Co., a biosimilar drug developer under Samsung Group, has announced its approval to market its biosimilar treatment for autoimmune diseases in Japan. This development marks a significant milestone for the company as it expands its presence in the international biopharmaceutical market.

According to Yonhap News Agency, the newly approved biosimilar references U.S. biotechnology firm Johnson and Johnson's original drug Stelara. It will be sold under the name Ustekinumab BS Subcutaneous Injection 45mg Syringes Nipro. The product is scheduled to launch in the Japanese market in May through a partnership with Japanese medical equipment manufacturer Nipro Corp. This collaboration marks Samsung Bioepis' first business partnership with a Japanese company, facilitating its entry into Japan's biopharmaceutical sector.

Jung Byoung-jin, vice president of Samsung Bioepis, highlighted Japan's significant investment in healthcare, allocating approximately 10 percent of its gross domestic product to the sector. This level of investment is among the highest within the Organization for Economic Cooperation and Development (OECD) countries. By offering biosimilars, Samsung Bioepis aims to alleviate the financial burden on Japan's healthcare system.

The same biosimilar is available under different names in various regions: Epyztek in South Korea and Pyzchiva in Europe and the United States. The global market for Stelara, the reference drug, is valued at 15 trillion won (US$10.36 billion), as reported by the company with data from Johnson and Johnson.

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