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# BLA Accepted for Herceptin Subcutaneous Formulation
- URL: https://www.fdaweb.com/bla-accepted-for-herceptin-subcutaneous-formulation/
- Published: 2018-07-11T12:00:00.000Z
- Updated: 2026-09-15T00:18:54.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5141844

FDA has accepted for review a Genentech BLA for a subcutaneous formulation of Herceptin (trastuzumab) and its use in FDA-approved breast cancer indications. This is a co-formulation with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE technology), which is approved and marketed under the Herceptin subcutaneous brand in many countries outside the U.S.