Halozyme Announces Approval Of Subcutaneous Formulation Of Trastuzumab (Herceptin) In Canada

Halozyme Therapeutics announced 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. This is a co-formulation with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE technology).

“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.