Celltrion is set to develop the increasingly in-demand 'Subcutaneous Injection (SC)' formulation. The company aims to differentiate itself by applying SC formulation conversion technology to biosimilars currently under development.

Celltrion announced on the 8th that it will apply SC conversion technology to new pipelines (new drug candidates) through the internalization of hyaluronidase-based SC formulation technology. The SC formulation is an injectable that can be administered directly under the skin. In contrast, the Intravenous (IV) formulation requires direct administration into a vein and takes over an hour.

Celltrion's SC formulation technology is based on the enzyme hyaluronidase, which breaks down hyaluronic acid, a component of the skin. By breaking down the densely packed hyaluronic acid in the skin, it creates space for the injection solution. This process enables subcutaneous injections. Previously, Celltrion developed 'Remsima SC', an SC formulation of the autoimmune disease biosimilar product 'Remsima', which is currently sold in the United States and Europe. According to the company, the newly developed SC formulation technology can be applied to higher-dose drugs using hyaluronidase compared to existing technologies.

Since February of this year, Celltrion has been conducting a clinical trial for regulatory approval of the breast cancer treatment 'Herzuma SC' using this technology. The company recently completed patient administration and plans to submit an application for additional approval of the Herzuma SC formulation to domestic and international regulatory agencies in the first half of next year (January to June). According to the company, changing from the existing intravenous injection, which took about 90 minutes, to the SC formulation can reduce the administration time to within 5 minutes.

The company stated that it plans to apply SC formulation technology to products currently developed or planned for development. Given that biosimilars are cheaper than original products, there is a risk of fierce competition, but the strategy is to secure differentiation through SC formulation conversion technology. In addition, Celltrion plans to expand its formulation change contract manufacturing (CMO) business for external clients. A Celltrion representative stated, "Once the development of Herzuma SC is completed, we will not only enhance product competitiveness but also be equipped to provide SC formulation conversion services to external clients."

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