CT P6 resubmitted to FDA as Herceptin biosimilar.- Celltrion.

Celltrion has made a resubmission to the FDA to obtain its marketing approval for CT P6, a proposed mAb biosimilar to Herceptin (trastuzumab). Celltrion submitted its abbreviated Biologics License Application (aBLA) for CT P6 to the FDA in May of last year. However, it received a CRL (complete response letter) from the FDA related to the warning letter issued by the FDA in January 2018, related to the manufacturing facility in Incheon, South Korea.

Comment: The reference product for CT P6 is Herceptin (trastuzumab). Herceptin is used to treat cancer patients whose tumors have either HER2 overexpression or HER2 gene amplification. Similarity of CT P6 to the reference product, Herceptin, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials. CT P6 is currently pending FDA review and approval. The final U.S. prescribing information for CT P6 will include the specific uses for which the product is indicated in the U.S. CT P6 was approved by the European Commission (EC) in early 2018 and launched in certain parts of Europe.