On 8 December 2025, Celltrion announced that it intends to expand its biosimilar pipeline by “internalising” hyaluronidase-based subcutaneous delivery (SC) formulation technology. According to Celltrion, its SC technology involves temporarily decomposing hyaluronic acid present in subcutaneous tissues to facilitate drug diffusion.
Celltrion’s announcement states that it has been conducting clinical trials for Herzuma® SC (CT-P6 SC), biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™) since February 2025 and plans to submit applications for approvals of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.
Herzuma® was launched in Europe in 2018 and in the US in March 2020.
Celltrion developed the world’s first subcutaneous injection of infliximab, Remsima SC®/Zymfentra®, which was launched in Europe in 2020 and in the US in 2024.