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

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

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  • The approval is based on non-inferiority data assessing Herzuma vs Herceptin (trastuzumab)- testing its safety- efficacy- PK &PD- and immunogenicity
  • The study demonstrated with bio-similarity in terms of purity- potency and safety between Herzuma and Herceptin in patients with HER2-overexpressing breast cancer
  • Herceptin biosimilar- Herzuma (trastuzumab-pkrb) is a HER2/neu receptor antagonist- approved by the US FDA as a combination therapy for adjuvant BC of HER2 and metastatic BC. In Oct- 2016 Celltrion and Teva collaborated to jointly promote Herzuma in the US and Canada

  Ref:  Celltrion | Image: Thailand Medical News

Click here to­ read the full press release 

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