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# FDA Accepts Mylan BLA for Biosimilar Herceptin
- URL: https://www.fdaweb.com/fda-accepts-mylan-bla-for-biosimilar-herceptin/
- Published: 2017-01-11T12:00:00.000Z
- Updated: 2026-09-14T21:59:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137693

FDA has accepted Mylan’s BLA for a proposed biosimilar trastuzumab (Genentech’s Herceptin), indicated to treat certain HER2-positive breast cancers. The company says that the anticipated FDA goal date under the Biosimilar User Fee Act is 9/3.