In a press release on Monday, the company said the trial met its primary endpoint, demonstrating pharmacokinetic equivalence to the reference product’s SC formulation, with comparable safety and immunogenicity. Herzuma SC is expected to reduce administration time to about five minutes, compared with roughly 90 minutes for the intravenous version, including post-infusion monitoring.
Following prior consultations with regulators, Celltrion plans to proceed with filings without additional clinical trials. Europe and Korea are currently the company’s largest markets for SC formulation products.
Herzuma SC was developed using Celltrion’s in-house hyaluronidase-based SC formulation platform, which temporarily breaks down hyaluronic acid in subcutaneous tissue to allow high-concentration, high-dose drugs to be administered safely and at scale. The company said the technology will be applied to future pipeline candidates and novel drug programs.
With Herzuma SC, Celltrion said it has established a fully integrated SC value chain spanning development, regulatory approval, manufacturing and commercialization — a structure it says offers a competitive edge over technology out-licensing models by retaining control across the entire lifecycle. The company also plans to expand into formulation-change contract manufacturing services, offering its SC expertise to external clients.
The launch would complement Celltrion’s existing portfolio, which includes Remsima SC (sold in the United States as Zymfentra), the world’s first commercialized infliximab SC. According to IQVIA, the global trastuzumab market was valued at about $3.56 billion in 2024.
The regulatory milestone comes as Celltrion posts its strongest financial performance on record. The company in late December projected a consolidated fourth-quarter revenue of 1.28 trillion won ($960 million) and operating profit of 472.2 billion won, up 20.7 percent and 140.4 percent year on year, respectively. The implied operating margin was 36.8 percent.
On a full-year basis, Celltrion forecasts 2025 revenue of 4.12 trillion won ($3.1 billion), a 15.7 percent increase from a year earlier, while operating profit is projected to surge 136.9 percent to 1.17 trillion won ($880 million) — the first time the company has surpassed 3 trillion won in annual revenue and 800 billion won in operating profit.
The company attributed the gains to steady growth in established products and rapid global expansion of newly launched, higher-margin biosimilars.
“Following the world’s first commercialization of infliximab SC, we have now secured hyaluronidase-based SC formulation technology and completed global-level SC capabilities,” a Celltrion official said. “We will accelerate global market share expansion and new growth engines, including CDMO services, by internalizing the full SC development cycle from productization to manufacturing and supply.”
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