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

Shots:

  • 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

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Twitter