FDA accepts BLA for subcutaneous formulation of Herceptin for approved indications.- Genentech/Halozyme Therapeutics.

Halozyme Therapeutics announced that the FDA has accepted a Biologics License Application from Genentech, a member of the Roche Group, for a subcutaneous (SC) formulation of Herceptin (trastuzumab) 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.

Enhanze drug delivery technology is based on patented recombinant human hyaluronidase enzyme, rHuPH20, to enable and optimize subcutaneous drug delivery for appropriate co-administered therapies. With the technology, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously, or under the skin, potentially providing a better experience for patients, and increasing health system efficiency by reducing administration time, injection pain and infusion site reactions.