NSP NEWS

(Seoul=NSP NEWS) = Celltrion has completed its application to the European Medicines Agency(EMA) for approval of ‘Herzuma SC,’ a subcutaneous formulation of the breast cancer treatment Herzuma, thereby securing a new hyaluronidase-based subcutaneous formulation platform.

By adding a hyaluronidase platform to its existing Remsima SC proprietary SC conversion technology, the company now possesses a total of two SC formulation technologies. The company expects to secure a leading position in the market upon approval, as there are currently no approved trastuzumab SC biosimilars.

According to Celltrion, there are currently no biosimilars approved for the trastuzumab SC formulation, and based on IQVIA, the global trastuzumab market size in 2025 is approximately $3.348 billion(approximately KRW 4.6872 trillion).

Celltrion plans to sequentially proceed with the approval process at regulatory agencies in major countries, starting with the European Medicines Agency(EMA).

Hyaluronidase temporarily breaks down hyaluronic acid in the subcutaneous tissue to facilitate drug diffusion, reducing the administration time from 90 minutes for conventional intravenous formulations to less than 5 minutes.