On July 11, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application from Genentech, a member of the Roche Group, for a subcutaneous (SC) formulation of trastuzumab (Herceptin) in its FDA-approved breast cancer indications (Press release, Halozyme, JUL 11, 2018, View Source [SID1234527649]). This is a co-formulation with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE technology), which is approved and marketed under the Herceptin SC brand in many countries outside the U.S.

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"We are excited to see Genentech and Roche taking steps to bring a subcutaneous formulation of trastuzumab to patients in the United States," said Dr. Helen Torley, president and chief executive officer. "If approved, this formulation would provide a new treatment administration option for patients and health care practitioners."

Roche reported total 2017 sales of Herceptin in the United States of 2.7 billion CHF. Sales of subcutaneous trastuzumab will be dependent on market adoption.

Herceptin (trastuzumab) is a registered trademark of Genentech, a member of the Roche Group.