Biotechnology company Halozyme Therapeutics Inc (NASDAQ:HALO ) stated on Monday that it has Health Canada approval for a subcutaneous (SC) formulation of trastuzumab (Herceptin SC) for the treatment of patients with HER2-positive breast cancer.
The Canadian approval was awarded to the company's partner Roche.
Herceptin SC is a co-formulation with Halozyme's proprietary recombinant human hyaluronidase enzyme (ENHANZE technology). Its 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). ENHANZE may 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.
In July 2018, the US Food and Drug Administration had accepted Genentech's Biologics License Application for the subcutaneous (SC) formulation of trastuzumab (Herceptin SC).
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