Celltrion announced on Thursday that it has completed its application to the European Medicines Agency (EMA) for the subcutaneous (SC) formulation of its breast cancer treatment, Herzuma (trastuzumab). The new formulation, named Herzuma SC (development code: CT-P6 SC), represents a significant advancement in drug delivery.
This move fulfills Celltrion’s February promise to submit the Herzuma SC application within three months, demonstrating the company’s commitment to timely product development. Celltrion plans to pursue approval with other major regulatory agencies worldwide, using the EMA application as a springboard.
The application is backed by clinical trial results directly comparing Herzuma SC with the original drug’s SC formulation. These trials successfully demonstrated pharmacokinetic (PK) equivalence as the primary endpoint, while also confirming comparable safety and immunogenicity profiles to the original product.
Herzuma SC is a groundbreaking product, being the first SC biosimilar to utilize Celltrion’s proprietary hyaluronidase platform. With no currently approved biosimilar products for the SC formulation of trastuzumab, Herzuma SC is poised to capture a significant early market advantage upon approval.
One of the key benefits of Herzuma SC is its dramatically reduced administration time. Compared to the intravenous (IV) formulation’s 90-minute infusion (or 30 minutes for maintenance therapy), Herzuma SC can be administered in about 5 minutes. This improvement not only enhances patient convenience by reducing treatment burden and hospital stay duration but also boosts healthcare provider efficiency and overall hospital operations.
Upon securing approval for Herzuma SC, Celltrion aims to offer a comprehensive ‘full lineup’ matching the original product, including both intravenous (IV) and SC formulations. This strategic move is expected to accelerate the company’s global market share expansion.
Celltrion plans to leverage its integrated SC full-cycle platform capabilities, which span development, approval, production, and supply, to venture into contract development and manufacturing organization (CDMO) projects. These initiatives will focus on offering formulation change technologies, further diversifying the company’s business model.
A Celltrion spokesperson emphasized that meeting the promised timeline for Herzuma SC’s European approval application showcases the company’s unique expertise in product development and regulatory navigation. The representative added that they’re set to maximize the global competitiveness by not only securing new pipelines based on the proprietary SC formulation technology but also by establishing a new growth engine in formulation change CDMO services.
European Market Gains Momentum for Key Product Lines
In a parallel development, Celltrion’s oncology and autoimmune disease treatments are showing robust growth across major European markets, strengthening the company’s overall business portfolio. The successful market integration of newly launched products is particularly noteworthy, significantly boosting Celltrion’s influence in Europe.
In the oncology sector, Celltrion’s Vegzelma (bevacizumab), a treatment for metastatic colorectal cancer and breast cancer, has secured a stable market share in Europe.
The drug has achieved notable success in France, winning key bids from major procurement organizations. These include Uniha, the country’s largest medical procurement agency representing major university hospitals, Acom, a purchasing group for public hospitals in Normandy, and Grapps, which represents regional public hospitals.
Impressively, Vegzelma now commands over half of the bevacizumab market share in France, underscoring Celltrion’s growing dominance in the European biopharmaceutical landscape.
