Celltrion said on the 30th that it has applied to the European Medicines Agency (EMA) for approval of the subcutaneous (SC) formulation "Herzuma SC (CT-P6 SC)" of its breast cancer treatment "Herzuma (ingredient name trastuzumab)."
Herzuma SC is the first SC-formulation biosimilar to apply Celltrion's independently developed hyaluronidase platform.
The SC formulation is characterized by significantly reducing administration time compared with the existing intravenous (IV) route. Herzuma SC shortens the IV administration time, which took about 90 minutes (30 minutes for maintenance therapy), to within 5 minutes, improving patient convenience and hospital operational efficiency.
The company said it confirmed similarity in pharmacokinetic (PK) equivalence, safety, and immunogenicity through a clinical trial comparing it with the original drug's SC formulation.
There are currently no approved trastuzumab SC-formulation biosimilars. Celltrion is seeking a first-mover advantage through this approval. By offering both IV and SC formulations of Herzuma, it aims to further strengthen its market dominance.
According to IQVIA, the global trastuzumab market is expected to reach about $3.3 billion (about 4.9 trillion won) in 2025.
The company said it plans to expand SC conversion for follow-on biosimilars and new drugs by internalizing a hyaluronidase platform in addition to the SC-switch technology secured with the autoimmune disease treatment "Remsima SC (U.S. name Zymfentra)." It also plans to pursue a formulation-switch contract development and manufacturing organization (CDMO) business based on an integrated SC platform that covers development, approval, production, and supply.