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Inspections and Audits

FDA Approves Mylan’s Herceptin Biosimilar

Dec. 6, 2017

The FDA approved Mylan’s Ogivri (trastuzumab-dkst), the first U.S. biosimilar for Genentech’s Herceptin, for the treatment of breast or metastatic stomach cancer with HER2-positive tumors.

Ogivri is the second FDA-approved cancer biosimilar — the first being Amgen’s Avastin biosimilar, Mvasi (bevacizumab-awwb), approved in September.

Ogivri was not approved as an interchangeable product. Like Herceptin, the biosimilar carries a Boxed Warning about increased risks of heart disease, infusion reactions, lung damage and pregnancy harms.

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