Biotechnology company Halozyme Therapeutics Inc (NASDAQ:HALO) said on Wednesday that it has successfully filed a Biologics License Application for a subcutaneous (SC) formulation of trastuzumab (Herceptin) under the US Food and Drug Administration's (FDA) approved breast cancer indications.
Herceptin is reportedly a registered trademark of Genentech and Herceptin's BLA has been submitted by Genentech, a member of the Roche Group.
For 2017, Roche reported sales of Herceptin of CHF2.7bn in the US. Sales of subcutaneous trastuzumab will be dependent on market adoption.
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 US.
(EUR1= CHF1.16)
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