HALOZYME THERAPEUTICS, INC: FDA Accepts Biologics License Application For Subcutaneous Formulation Of Herceptin

Source: Halozyme Therapeutics, Inc.

Halozyme Therapeutics, Inc. issued the following announcement on July 11.

Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced 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. 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.

"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.

Original source can be found here.

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Halozyme Therapeutics, Inc. 11388 Sorrento Valley Rd San Diego, CA 92121-1345