On September 17, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Roche has received approval from Health Canada for a subcutaneous (SC) formulation of trastuzumab (Herceptin SC) for the treatment of patients with HER2-positive breast cancer (Press release, Halozyme, SEP 17, 2018, View Source [SID1234529462]). This is a co-formulation with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE technology).

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"We are pleased that the subcutaneous formulation of trastuzumab (Herceptin SC) has been approved in Canada," said Dr. Helen Torley, president and chief executive officer. "Patients and health care providers will now have another treatment option with the potential for a reduced administration time."

The U.S. Food and Drug Administration accepted a Biologics License Application from Genentech for a subcutaneous (SC) formulation of trastuzumab (Herceptin SC) in July 2018.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.