Celltrion is moving to expand its product lineup of subcutaneous (SC) formulation drugs in earnest. The SC formulation is a method of injecting a drug directly into the subcutaneous tissue, namely the fat layer beneath the skin. It is characterized as a formulation that can improve treatment convenience for healthcare professionals and patients by addressing the drawbacks of intravenous (IV) administration, which requires a long infusion time, while offering comparable efficacy. Domestic company Alteogen holds SC formulation platform technology and is attracting significant attention in this field. In Celltrion’s case, the SC formulation of its autoimmune disease treatment Remsima (infliximab), Remsima SC, has been approved as a new drug in the United States, the world’s largest market, and is being sold under the name “Zymfentra.” It is cited as a key example that demonstrates strong regulatory and market interest in SC formulations as well as differentiated competitiveness.

Celltrion announced on the 2nd that it has successfully completed a pivotal clinical trial for the approval of “Herzuma SC (CT-P6 SC),” the SC formulation of its breast cancer treatment “Herzuma” (ingredient name trastuzumab). The company plans to file marketing authorization applications with regulatory authorities in major markets, including Europe and Korea, within three months.

In the pivotal CT-P6 SC trial, in which dosing was recently completed, the company directly compared the original product’s SC formulation with CT-P6 SC and demonstrated pharmacokinetic (PK) equivalence, which was the primary endpoint. It also confirmed equivalence in terms of safety and immunogenicity. Following the successful development and commercialization of the biosimilar Herzuma, Celltrion has now successfully completed a pivotal clinical trial for the SC formulation biosimilar that additionally applies the enzyme hyaluronidase. The company is assessed to have proven its outstanding development capabilities by internalizing hyaluronidase-based SC formulation technology. This technology temporarily degrades hyaluronic acid in subcutaneous tissue, enabling SC administration of high-concentration, high-dose drugs, and is regarded as a technology with high safety and expandability.

According to Celltrion, as it has secured sufficient data on quality and PK equivalence compared with the original product, it plans to apply for product approval for domestic and European sales within three months without additional clinical trials, in line with prior agreements with regulatory authorities. Celltrion explained that for Herzuma SC, the drug administration time, which currently takes about 90 minutes (30 minutes for maintenance therapy) with the existing IV formulation, can be reduced to within approximately 5 minutes. This is expected to significantly improve patient treatment convenience and broaden options for healthcare professionals. Sales synergies are also anticipated from having a full product lineup. According to pharmaceutical market research firm IQVIA and others, the global trastuzumab market is estimated to be approximately KRW 4,985.4 billion as of 2024.

Starting with Herzuma SC, Celltrion will establish the only full value chain in Korea encompassing development, approval, mass production, and global supply related to SC formulations. It will complete a proprietary, integrated development platform that covers the entire lifecycle of SC formulation development. Unlike a licensing-out (L/O) model, in which only certain technologies are transferred externally, Celltrion is evaluated to have secured a differentiated competitive edge in terms of long-term profitability and strategic flexibility through a vertically integrated structure that directly controls the full cycle from development to commercialization and sales. It is also considered strategically significant in that the company has built a medium- to long-term growth platform leveraging SC formulation technology, going beyond the success of a single product.

Upon completion of Herzuma SC’s development, Celltrion will join the ranks of “first movers” that have applied hyaluronidase to biosimilars for the first time. It is expected to become a leading case in the SC formulation biosimilar market. As the company is likely to secure first-mover advantage, analysts expect it will be able to maximize both product competitiveness and profitability. In particular, Celltrion plans to actively apply SC formulations to new drugs it develops in the future.

A Celltrion official said, “Building on the development of Herzuma SC, we also plan to pursue expansion into a formulation-change contract manufacturing (CMO) business that provides SC formulation conversion capabilities to external clients,” adding, “Based on our overwhelming competitiveness derived from full internalization of end-to-end SC formulation development, we will accelerate the expansion of new businesses such as global market share growth and contract development and manufacturing (CDMO).”

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