Teva On Tenterhooks Over Fremanezumab As Celltrion Gets CRLs

The nail-biting at Teva Pharmaceutical Industries Ltd. over whether its investigational migraine drug fremanezumab will get US approval by the summer is going to continue for a while as the manufacturing problems at partner Celltrion Inc.'s facility where the active ingredient is made have come to a head.

The trouble started in January when the FDA issued a warning letter to Celltrion citing an extensive number of GMP violations with many of the problems stemming from relaxed contamination controls. Now Teva has confirmed that its partner has received complete response letters (CLRs) from the FDA regarding two Biologics License Applications for two biosimilars the companies are seeking approval for - CT-P6 (trastuzumab) and CT-P10 (rituximab), versions of Roche's Herceptin and Rituxan, respectively