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

Shots:

• 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

  Click here read full press release/ article | Ref:  Celltrion | Image: Thailand Medical News