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Teva On Tenterhooks Over Fremanezumab As Celltrion Gets CRLs

 
• By Kevin Grogan

The FDA is not approving two biosimilars from Teva and Celltrion over concerns about the latter's facility, leading to more speculation that approval of the Israeli firm's potential migraine blockbuster, manufactured at the same plant, may be delayed.

Nervous
Nerve-wracking time for Teva • Source: Shutterstock

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...

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