CT-P6 SC (trastuzumab SC biosimilar) / Celltrion - LARVOL DELTA

Celltrion announced on Monday that it has completed the regulatory clinical trial for Herzuma SC (developed as CT-P6 SC), the subcutaneous formulation of the breast cancer treatment Herzuma (trastuzumab) (Korea Biomedical Review) - "The recently completed CT-P6 SC approval clinical trial directly compared CT-P6 SC with the SC formulation of the originator product, demonstrating pharmacokinetic (PK) equivalence, the key evaluation variable....Having secured sufficient quality and PK equivalence data compared to the originator, the company plans to apply for marketing authorization for Herzuma SC in Europe and Korea within three months without additional clinical trials, as previously agreed with regulatory authorities."

EMA filing • Korea filing • Trial completion • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Positive Breast Cancer

To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) (clinicaltrials.gov) - P1 | N=200 | Active, not recruiting | Sponsor: Celltrion | Recruiting ➔ Active, not recruiting

Enrollment closed

Celltrion expands subcutaneous pipeline as Herzuma SC heads to trial (Korea Biomedical Review) - "On Thursday, the Ministry of Food and Drug Safety (MFDS) greenlit a phase 1 clinical trial for CT-P6 SC, Celltrion’s SC version of Herzuma, its biosimilar to Roche’s Herceptin (trastuzumab). The trial will compare the pharmacokinetics, safety, and immunogenicity of CT-P6 SC against Genentech’s Herceptin Hylecta, which combines trastuzumab with recombinant human hyaluronidase to enable subcutaneous injection."

New P1 trial • Oncology