三星Bioepis推进自有SC制剂技术，Celltrion已布局赫赛汀和达雷妥尤单抗SC生物类似药

As Samsung Bioepis secures subcutaneous injection (SC) formulation technology on its own, the global biosimilar competition is expanding into "formulation conversion." Celltrion (068270.KS) has already internalized PH20-based technology and last year began developing biosimilars for Herceptin SC and Darzalex SC. Some observers suggest that biosimilar developers could launch SC products immediately in line with the expiration of the original products' substance patents. Accordingly, SC formulation competition between the two major biosimilar companies and Big Pharma is expected to intensify.
According to the biotech industry on the 13th, Samsung Bioepis is reviewing plans to apply SC formulations. With the company currently developing biosimilars for Keytruda and Enhertu, it is observed that Samsung Bioepis is likely to apply the technology first to these two drugs. An industry official said, "Since waiting for the patent expiration of original SC products could delay market entry, the key will be when to begin development."
Merck's (MSD) Keytruda is the world's top anticancer drug, generating $31.7 billion in sales last year alone. MSD plans to convert 40% of the entire Keytruda market to the SC formulation "Keytruda Qlex" by the end of next year. By simple calculation, this creates a $12.7 billion market in the SC formulation alone. Market research firm Mordor Intelligence forecast that the global SC biopharmaceutical market will grow from $286.3 billion this year to $498.9 billion in 2031.
Samsung Bioepis moved to internalize PH20-based SC formulation technology because global Big Pharma companies are extending their market monopoly through SC formulations. In fact, after Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval for "Darzalex Faspro," the SC formulation of Darzalex, in 2020, it converted more than 80% of existing Darzalex patients (85% in the U.S., 80% in Europe) to Darzalex Faspro in about two years. Ahead of the Darzalex (IV) patent expiration in 2030, this leaves biosimilar companies with less than 20% of the market. Compared to the IV formulation, the SC formulation reduces administration time from several hours to several minutes and shortens hospital stays, making it highly preferred by both patients and medical staff.
Amid this market trend, Celltrion has already moved to secure the world's first SC formulation biosimilar applying hyaluronidase. It has been conducting approval clinical trials for Herzuma SC (CT-P6 SC) since February last year, and also began clinical trials of the SC formulation (CT-P44) for a Darzalex biosimilar in August last year. Celltrion is also considering expanding not only new drugs but also formulation-change CMO business for external clients. In contrast, it has been confirmed that Samsung Bioepis is not considering providing formulation-change technology externally.
Notably, both of Korea's two major biosimilar companies have secured their own SC platforms. Global biosimilar companies Sandoz of Switzerland and Intas of India also signed contracts with Korean company Alteogen and licensed in SC formulation-change technology. However, Alteogen has signed exclusive contracts with MSD for the Keytruda ingredient and with Daiichi Sankyo for the Enhertu ingredient. Sandoz and Intas find it difficult to apply Alteogen's technology to Keytruda and Enhertu biosimilars. Halozyme, which participated in developing blockbuster SC formulations such as Herceptin, Darzalex, and Rybrevant, also provides its technology exclusively.
An industry official forecast, "As platform companies sign exclusive contracts with Big Pharma for each ingredient, biosimilar companies without their own technology now have to wait until the SC formulation patents expire," adding, "While the possibility of patent disputes cannot be completely ruled out even with proprietary technology, it has the advantage of relatively lower risk and can be applied to various products once patent issues are resolved." The point is that building an SC platform based on a proprietary sequence allows for the use of a universal platform. Furthermore, there is a possibility of moving away from the strategy of chasing the patent expiration timing of original drugs and entering SC formulation competition immediately when substance patents are lifted.
Production synergy with affiliates is also expected. Samsung Bioepis' affiliate Samsung Biologics plans to expand its production lines for pre-filled syringes (PFS) and auto-injectors used in SC formulations by 2027. These facilities can be derivatively utilized for the production of drug products (DP) for SC formulation biosimilars in the future. Celltrion's affiliate Celltrion Pharm has also disclosed a plan to invest 2 trillion won in the Chungcheongbuk-do region to expand PFS production capacity from the current 20 million syringes to 70 million syringes per year.