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

Celltrion Pharm

10/10/2018 16:29

Oct 10 (Reuters) - An advisory panel to the U.S. Food and
Drug Administration on Wednesday voted unanimously in favor of
Celltrion Pharm Inc's  068760.KQ  copycat drug of Roche Holding
AG's  ROG.S  blood cancer drug Rituxan.
    The panel vote comes after the FDA staff reviewers https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM622649.pdf
 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 https://www.celltrion.com/en/pr/newsDetail.do?seq=482
 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  TEVA.TA  to commercialize
CT-P10 in the United States and Canada. 

 (Reporting by Ankur Banerjee in Bengaluru; Editing by Shailesh
Kuber)
 ((ankur.banerjee@thomsonreuters.com; @AnkurBanerjee17; within
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