Shots:

• The P-III trial involves assessing the safety- immunogenicity and PK of EG12014 (trastuzumab- biosimilar) vs Herceptin in 807 patients in a ratio (1:1) for HER2-positive breast cancer
• The trial met its 1EPs showed equivalent efficacy to Herceptin in regards to clinical response (pCR) in both analysis populations (per-protocol and full-analysis sets) and demonstrated a comparable safety profile in the pre-operative treatment setting
• The company is preparing to submit BLA to the US FDA- MAA to EMA and NDA to TFDA

 ­ Ref: PRNewswire | Image: Novatek International