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Teva Canada's Herzuma (biosimilar- trastuzumab) Receives Health Canada Approval for Multiple Cancer Indications

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Teva Canada's Herzuma (biosimilar- trastuzumab) Receives Health Canada Approval for Multiple Cancer Indications

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  • Health Canada has granted notice of compliance for Teva Canada’s Herzuma for the treatment of early breast cancer (EBC)- metastatic breast cancer (MBC) and metastatic gastric cancer (MGC) in Canada
  • The Health Canada NOC is based on efficacy- safety- quality- immunogenicity- PK/PD data from non-clinical and clinical studies- demonstrating that Herzuma and Herceptin has high bio similarity in terms of purity- potency and safety for the three approved indications
  • Herzuma is a mAb biosimilar of the reference product- Herceptin targeting ECD of HER2 receptor and has received MFDS- EC and the FDA’s approval in Jan’2014- Feb’2018 and Dec’2018 respectively

Click here to­ read full press release/ article | Ref: Newswire Canada | Image: ImgBin


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