FDA Approves New Trastuzumab Product

On February 28, 2019, the FDA approved Genentech’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk).  According to a press release from Roche, Genentech’s parent company:  “This new treatment includes the same monoclonal antibody as intravenous Herceptin® (trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin.  Herceptin Hylecta is a ready-to-use formulation that can be administered in two to five minutes, compared to 30 to 90 minutes for intravenous Herceptin.”

The FDA has approved three biosimilars to the original Herceptin (trastuzumab) product, none of which have yet been marketed in the United States.

 

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