On 30 April 2026, Celltrion announced that it had submitted an application to the European Medicines Agency (EMA) for Herzuma® SC/CT-P6 SC, biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™).
The timing of the application 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 approvals of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026. According to Celltrion, following the EMA, 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.