Samsung Bioepis称已完成自研PH20皮下注射转换技术内部测试，但未确定适用药物

Samsung Bioepis, a subsidiary of Samsung Epis Holdings (0126Z0), has secured technology to convert drugs into subcutaneous (SC) formulations based on recombinant human hyaluronidase (PH20). As global blockbuster drugs such as Keytruda shift to SC formulations and raise patent barriers, the company is expected to accelerate its push into the biosimilar market using its own technology.
According to the biotech industry on the 13th, Samsung Bioepis has completed internal testing of its PH20-based SC formulation conversion technology. The company reportedly used its own hyaluronidase, different from those used by Halozyme in the United States and Alteogen in Korea, and also independently developed the cultivation and purification processes. Since the substance and the cultivation and purification processes are all subject to patent disputes, the move is analyzed as an effort to minimize intellectual property risks through proprietary technology.
PH20-based SC formulation conversion technology is a core technology needed to convert high-dose antibody drugs from intravenous (IV) to SC formulations. Benepali SC (original drug Enbrel) and Imraldi SC (Humira), which Samsung Bioepis developed in the past, were low-dose antibody drugs, so SC formulation development was possible through concentration adjustment alone. However, most blockbuster cancer drugs recently launched are high-dose, and converting them to SC formulations requires PH20-based technology that temporarily breaks down the physical barrier of subcutaneous tissue.
Samsung Bioepis is expected to apply this technology to Keytruda, the top-selling cancer drug globally from Merck (MSD) of the United States, for which it is developing a biosimilar, and to Enhertu, a leading antibody-drug conjugate (ADC) product from Japan's Daiichi Sankyo. A Samsung Bioepis official drew a line, saying, "Nothing has been officially decided regarding which drugs the technology will be used for."