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

Celltrion and Teva’s Herzuma (trastuzumab-pkrb, Herceptin biosimilar) Receives FDA’s Approval for HER2-Overexpressing Breast Cancer

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

Click here to read full press release/ article | Ref:  Businesswire  | Image: The investors

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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