Celltrion Receives Complete Response Letters for Two Biosimilars

Celltrion received two complete response letters from the FDA regarding biologics license applications for Truxima (rituximab) and Herzuma (trastuzumab) — biosimilars of Roche`s blockbuster cancer drugs Rituxan and Herceptin.

The CRLs were directly related to a warning letter issued to Celltrion in January after an inspection of its Incheon, South Korea facility.

The agency found microbial contamination risks and inadequate training in addition to media fill deficiencies. The investigator found that the firm received approximately 140 critical complaints for vial stopper issues that could significantly impact quality attributes over a product’s shelf life. Recurring complaints were investigated by the firm but they went unresolved for over two years.