Celltrion Internalizes Hyaluronidase-Based Subcutaneous Formulation Technology to Expand Biosimilar Pipeline
核心洞察
Celltrion announced the internalization of hyaluronidase-based subcutaneous formulation technology that enables conversion of intravenous drugs to subcutaneous injections.
The company is conducting clinical trials for Herzuma SC (搜索), which reduces administration time from 90 minutes to under 5 minutes compared to the intravenous formulation.
Celltrion plans to leverage this technology for contract manufacturing services and expand SC conversion across its biosimilar portfolio and new drug pipelines.
Celltrion announced on December 8 that it has internalized hyaluronidase-based subcutaneous (SC) formulation technology, positioning the South Korean biopharmaceutical company to expand its biosimilar pipeline through conversion of intravenous therapies to more convenient subcutaneous injections.
The internalized technology works by temporarily decomposing hyaluronic acid (HA) present in subcutaneous tissue to facilitate drug diffusion. HA degradation expands the tissue space at the injection site and increases absorption, while the degraded HA regenerates naturally over time, making it relatively free from safety concerns. These characteristics enable the development of relatively high-concentration and high-capacity products in subcutaneous form.
Clinical Development of Herzuma SC
Celltrion has been conducting clinical trials for Herzuma SC (搜索) (development code CT-P6 SC) using this technology since February 2024. The company recently completed patient dosing and plans to submit applications for additional approval of the Herzuma SC formulation to domestic and international regulatory agencies in the first half of 2025.
The subcutaneous formulation offers significant advantages in administration efficiency. While the existing intravenous formulation requires approximately 90 minutes for administration (30 minutes for maintenance therapy), switching to the SC formulation reduces administration time to within approximately 5 minutes.
Herzuma, an anti-cancer (搜索) antibody biosimilar, currently demonstrates strong market performance with a 75% market share in Japan, ranking first, and has expanded to a 32% market share in Europe. Celltrion expects that adding the SC formulation will secure a full product lineup with both IV and SC options, further accelerating market expansion.
Strategic Positioning and Competitive Advantages
The internalization of hyaluronidase-based SC formulation technology complements Celltrion's existing experience in commercializing the world's first infliximab SC (Remsima SC, marketed in the US as Zymfentra (搜索)) in global markets. This combination provides the company with comprehensive capabilities for customized SC development.
Celltrion has established itself as the only domestic company with a full value chain covering the entire process from SC formulation productization, approval, mass production, to global supply. This structural differentiation provides a unique competitive advantage compared to companies that possess only single technology capabilities.
Contract Manufacturing Expansion
Based on its customized SC formulation development capabilities, Celltrion plans to pursue contract manufacturing organization (CMO) business for formulation changes of externally commissioned products. The company believes it can provide one-stop services across the entire SC conversion process, backed by its customized SC conversion technology, global commercial production infrastructure, and experience with major regulatory approvals.
These services show high promise as they can be applied not only to biosimilars but also to high-dose biologics such as anticancer drugs and autoimmune disease (搜索) treatments.
Future Growth Strategy
Celltrion plans to implement a step-by-step SC technology-based growth strategy focused on three pillars: SC conversion of its biosimilar product lineup, SC application to new drug pipelines, and expansion of formulation change CMO business for external clients.
"SC conversion technology is an area of high interest for global pharmaceutical companies because it enhances patient convenience and improves hospital operational efficiency, but there are not many companies with integrated capabilities across the entire process," a Celltrion official stated. "Once the development of Herzuma SC (搜索) is completed, we will be equipped not only to enhance product competitiveness but also to provide SC formulation conversion services to external clients."