FDA accepts biologics license application for subcutaneous formulation of Herceptin

Halozyme Therapeutics

11 July 2018 - Halozyme Therapeutics today announced that the U.S. FDA has accepted a biologics license application from Genentech, a member of the Roche Group, for a subcutaneous 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 subcutaneous brand in many countries outside the U.S.

Read Halozyme Therapeutics press release


Michael Wonder

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Michael Wonder

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