Celltrion

• Celltrion has successfully completed the pivotal regulatory clinical trial for Herzuma SC and plans to submit marketing authorization applications within the next three months, starting with Europe and Korea, its largest markets for SC formulation products.
• The trial demonstrated pharmacokinetic (PK) equivalence as well as comparable safety and immunogenicity to the reference product, and Herzuma SC is expected to reduce administration time to approximately five minutes.
• Celltrion plans to leverage its hyaluronidase-based SC formulation platform for subsequent pipeline candidates as well as for the development of novel drug programs.
• By establishing a full SC value chain spanning development, regulatory approval, manufacturing, and commercialization, Celltrion has secured differentiated competitiveness beyond simple technology out-licensing models.
• Building on its advanced SC formulation capabilities, Celltrion also aims to expand its business scope into formulation-change CMO services.

INCHEON, South Korea- Celltrion announced today that it has successfully completed the regulatory clinical trial for ‘Herzuma SC(CT-P6 SC)’, the subcutaneous (SC) formulation of the breast cancer treatment ‘Herzuma (trastuzumab)’, plans to submit marketing authorization applications to regulatory authorities in Europe and Korea within the next three months.

In the recently completed pivotal trial for CT-P6 SC, Celltrion directly compared CT-P6 SC with the reference product’s SC formulation and successfully demonstrated pharmacokinetic (PK) equivalence, the primary endpoint of the study. Furthermore, it confirmed equivalence to the originator product in safety and immunogenicity assessments. With this, Celltrion has once again demonstrated its unparalleled development capabilities. Following the successful development and commercialization of the biosimilar Herzuma, it has now successfully completed the regulatory clinical trial for an SC formulation biosimilar incorporating the enzyme hyaluronidase.

The company has secured sufficient data on quality and PK equivalence compared to the original product. Accordingly, following prior consultations with regulatory authorities, it plans to apply for marketing authorization for Herzuma SC in Europe and domestically within three months without conducting additional clinical trials. Europe and Korea currently represent Celltrion’s largest markets for SC formulation products.

Celltrion developed Herzuma SC by internalizing hyaluronidase-based SC formulation technology. This technology temporarily breaks down hyaluronic acid within subcutaneous tissue, enabling the SC administration of high-concentration, high-dose pharmaceuticals, which offers high safety and scalability.

Additionally, Herzuma SC is expected to maximize patient convenience by reducing the administration time from approximately 90 minutes (including a 30-minute maintenance period) for the existing intravenous (IV) formulation to within about 5 minutes, while also broadening the options available to healthcare providers. Upon approval, Celltrion is expected to accelerate its expansion of global market share by securing a full product lineup encompassing both IV and SC formulations. According to IQVIA, the global trastuzumab market size reached approximately $3.561 billion as of 2024.

Celltrion has completed its own integrated development platform spanning the entire SC formulation development lifecycle, establishing Korea's only full SC value chain encompassing development, approval, mass production, and global supply starting with this Herzuma SC. Unlike the license-out (L/O) approach, which transfers only partial technology externally, this structure enables direct control over the entire cycle from development to commercialization and sales. It is evaluated as securing a differentiated structural competitive advantage in terms of long-term profitability and strategic flexibility. It also holds significant strategic meaning in establishing a mid-to-long-term growth platform leveraging SC formulation technology, going beyond the success of a single product.

Once the development of Herzuma SC is completed, Celltrion is expected to join the ranks of ‘first movers’ by being the first to apply hyaluronidase to a biosimilar, establishing itself as a leading example for biosimilars in this formulation. As this milestone is anticipated to secure a market advantage, the company expects to maximize both product competitiveness and profitability. Celltrion plans to actively consider applying the SC formulation to its own biosimilars as well as new drugs under development in the future, if necessary.

Celltrion has already demonstrated its capability to commercialize SC formulations through Remsima SC (US product name: Zymfentra). Building on this, the company plans to expand into contract manufacturing (CMO) services for formulation changes, offering its SC formulation modification expertise to external clients as well.

“Following the world’s first commercialization of infliximab SC, we have now secured hyaluronidase-based SC formulation technology, completing global-level SC formulation capabilities,” said an official at Celltrion. “Beyond this, we will accelerate global market share expansion and new business growth such as contract development and manufacturing (CDMO), based on our overwhelming competitive advantage of full-cycle SC formulation development internalization—from productization to manufacturing and supply.”