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U.S. FDA panel backs Celltrion biosimilar

Written by: | | Dated: Wednesday, October 10th, 2018


U.S. FDA panel backs Celltrion copycat drug of Roche blood cancer drug


(Reuters) – An advisory panel to the U.S. Food and Drug Administration on Wednesday voted unanimously in favor of Celltrion Pharm Inc’s copycat drug of Roche Holding AG’s blood cancer drug Rituxan.

The panel vote comes after the FDA staff reviewers here said Cellltrion’s biosimilar, CT-P10, is highly similar to Rituxan. The FDA usually, but not always, follows the advice of its advisory panels.

The agency had declined to approve here the copycat drug in February, citing issues related to certain manufacturing process at the company’s facility.

Celltrion has entered into an exclusive partnership with Teva Pharmaceutical Industries Ltd to commercialize CT-P10 in the United States and Canada.


Reporting by Ankur Banerjee in Bengaluru; Editing by Shailesh Kuber


Reuters source:

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