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Celltrion and Teva Announces Approval Recommendations for CT-P10's (rituximab- biosimilar) BLA from the US FDA ODAC

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Celltrion and Teva Announces Approval Recommendations for CT-P10's (rituximab- biosimilar) BLA from the US FDA ODAC

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  • FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 16-0 in favor of CT-P10 and recommended it on the basis of analytical biosimilarity- nonclinical & clinical pharmacology- immunogenicity- efficacy and safety data with no difference in safety- purity- and potency b/w CT-P10 and Rituxan
  • Teva to acquire commercialization rights for CT-P10 post-FDA approval in three indications and is currently approved in 47 countries worldwide. In 2016- Celltrion and Teva entered into a collaboration to commercialize CT-P10 in the US and Canada
  • Rituxan’s biosimilar is recommended in indications r/r- CD20-positive- B-cell (NHL); previously untreated follicular- CD20-positive- B-cell NHL + 1L CT; non-progressing CD20-positive- B-cell NHL 1L cyclophosphamide- vincristine- and prednisone CT

Ref:  Businesswire  | Image: Celltrion

Click here to­ read the full press release 

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