Celltrion said Thursday it has submitted an application to the European Medicines Agency (EMA) to add a subcutaneous formulation of Herzuma (trastuzumab), its breast cancer biosimilar referencing Herceptin.
Celltrion headquarters in Songdo, Incheon. (Credit: Celltrion)
The filing comes within three months of Celltrion’s announcement in early February that it planned to submit the European application for Herzuma SC within that period.
Celltrion said it plans to proceed with regulatory submissions in other major markets following the EMA filing.
The application was based on clinical data directly comparing Herzuma SC with the subcutaneous formulation of the original drug. In the trial, Herzuma SC demonstrated pharmacokinetic equivalence, the key endpoint, while also showing comparable safety and immunogenicity profiles to the originator product, the company said.
Herzuma SC is the first subcutaneous biosimilar formulation developed using Celltrion’s internally developed hyaluronidase platform. As there is currently no approved biosimilar for the subcutaneous formulation of trastuzumab, Celltrion expects Herzuma SC to gain a significant early-mover advantage if approved.
The subcutaneous formulation sharply reduces administration time compared with the intravenous version. While the IV formulation takes about 90 minutes for initial administration and 30 minutes for maintenance therapy, Herzuma SC can be administered in about five minutes or less.
Celltrion said the shorter administration time is expected to ease the treatment burden on patients and reduce hospital stays, while also improving administration efficiency for healthcare professionals and operational efficiency for hospitals.
According to pharmaceutical market research firm IQVIA, the global trastuzumab market was valued at about $3.35 billion in 2025.
Celltrion said Herzuma SC also represents an important step in strengthening its formulation technology platform. In addition to its proprietary SC conversion technology already proven through Remsima SC, marketed in the U.S. as Zymfentra, the company has now internalized a hyaluronidase-based platform, giving it two types of SC formulation technologies.
Celltrion also plans to expand into a contract development and manufacturing business that provides formulation-change technologies, based on its integrated SC platform covering development, regulatory approval, production and supply.
“Completing the European application for Herzuma SC within the timeline promised to the market reflects Celltrion’s unique product development and regulatory capabilities,” a Celltrion official said. “Based on our internalized SC formulation conversion technology, we will maximize global competitiveness by securing new pipelines and creating a new growth driver in formulation-change CDMO.”
Lee Han-soo
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