Mylan and Biocon Launch Ogivri (biosimilar, trastuzumab) in the US

 Mylan and Biocon Launch Ogivri (biosimilar, trastuzumab) in the US

Biocon and Mylan’s Ogivri (trastuzumab, biosimilar) Receives Health Canada’s Approval for HER2-Positive Breast and Gastric Cancers


  • The FDA’s approval is based on study assessing Ogivri vs Herceptin with docetaxel or paclitaxel in 456 patients with measurable HER2+ mBC without prior chemotherapy or trastuzumab for metastatic disease
  • The study demonstrated equivalence in overall response @24wks. with equivalence margin (0.81, 1.24) showing no clinically meaningful differences in terms of safety, purity and potency
  • Ogrivi (trastuzumab-dkst) is a biosimilar to Herceptin will be available as 420 mg multi-dose vial & 150 mg single-dose vial and is the second FDA approved biosimilar developed by Mylan and Biocon. Additionally, the companies have co-developed globally 11 biosimilars

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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

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