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