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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

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

Shots:

  • 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


Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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