Celltrion completes Herceptin biosimilar resubmission with FDA

South Korean company Celltrion (KRX: 068270) has made a resubmission to the US Food and Drug Administration to obtain its marketing approval for CT-P6, a proposed monoclonal antibody (MAb) biosimilar to Swiss pharma giant Roche’s (ROG: SIX) Herceptin(trastuzumab), which reported sales of around $7.1 billion last year.

Celltrion submitted its abbreviated Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last year, respectively. However, it received (complete response letters (CRLs) from the FDA related to the warning letter issued by the FDA in January 2018, related to the manufacturing facility in Incheon, South Korea.

The company has also had rebuff from the FDA for CT-P10, referencing Roche’s Rituxan (rituximab).