Research & Development
Halozyme Therapeutics Inc announces filing of Herceptin BLA with the US FDA for breast cancer
12 July 2018 -

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)