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

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

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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