It is expected that Herjuema, Celltrion's anticancer drug, will be able to be administered as a subcutaneous (SC) injection in under five minutes. Celltrion said on Dec. 8 that it plans to submit applications for additional approval of the subcutaneous injection formulation of Herjuema to domestic and overseas regulators in the first half of next year.
When administered intravenously by medical staff, Herjuema previously took about 90 minutes. Celltrion applied a technology to Herjuema that breaks down hyaluronic acid in subcutaneous tissue so the drug can be absorbed quickly. This reduces the administration time to five minutes. Celltrion completed patient dosing in February during clinical trials of the subcutaneous injection of Herjuema.
The company plans to apply subcutaneous injection technology to its biosimilar and novel drug pipelines. It will expand its contract manufacturing organization (CMO) business that converts intravenous therapies into subcutaneous formulations for external clients. The company said it can provide contract manufacturing services based on its commercial production infrastructure and experience with approvals from major regulators.
A Celltrion official said, "Because it improves patient convenience and the operational efficiency of hospitals and clinics, global pharmaceutical companies are interested in subcutaneous injection technology," adding, "once development of the subcutaneous injection formulation of Herjuema is completed, we will be able to offer related services to external clients."