On 28 May 2026, The Seoul Economic Daily reported that Celltrion has filed an application with the Korean Ministry of Food and Drug Safety for approval of Herzuma® SC/CT-P6 SC, biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™). The subcutaneous (SC) application was submitted for all Herceptin® SC indications, including the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.
This follows Celltrion’s announcement on 30 April 2026 that it had submitted an application to the European Medicines Agency (EMA) for Herzuma® SC. The timing of these applications aligns with Celltrion’s December 2025 announcement that it had been conducting clinical trials for Herzuma® SC (CT-P6 SC) since February 2025 and planned to submit applications for approval of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026. According to Celltrion, it plans to proceed with regulatory submissions for Herzuma® SC in other major countries.
There are currently no biosimilar SC formulations of trastuzumab on the market and Celltrion considers it is well-placed to enjoy a “first mover” advantage. In January 2026, Biocon Biologics announced that it had added a trastuzumab/hyaluronidase product, referencing Roche’s Herceptin® SC/Herceptin Hylecta™, to its biosimilar development pipeline.