Shots:

• The approval is based on positive opinion by CHMP (EMA) assessing Herzuma and reference trastuzumab in patients with HER2 overexpression/gene amplification tumors in breast cancer- metastatic breast cancer and metastatic gastric cancer
• The study resulted in a non-inferiority data demonstrating efficacy- safety- immunogenicity- PD and PK in patients
• Herzuma (trastuzumab biosimilar- CT-P6) is a mAb- that binds to extracellular domain of human epidermal growth factor receptor (HER2) and is currently reviewed by FDA review in the USS

Ref: Celltrion | Image: Celltrion