Teva Canada’s Herzuma (biosimilar, trastuzumab) Receives Health Canada Approval for Multiple Cancer Indications

Teva Canada’s Herzuma (biosimilar, transtuzumab) Receives Health Canada Approval for Multiple Cancer Indications

Shots:

  • 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