FDA Accepts Genentech’s Biologics License Application
Halozyme Therapeutics, Inc. recently announced that the US FDA has accepted Genentech’s Biologics License Application for a subcutaneous formulation of rituximab in multiple blood cancer indications. This is a co-formulation with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE platform), approved and marketed under the MabThera SC brand in countries outside the US.
“We are excited to see Genentech and Roche taking steps to bring a subcutaneous formulation of rituximab to patients in the United States,” said Dr. Helen Torley, President and Chief Executive Officer. “If approved, this formulation has the potential to reduce administration time for patients and healthcare practitioners.”
Including all approved indications, Roche reported total 2015 sales of rituximab in the United States of 3.76 billion CHF.
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer, and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies, including Roche, Baxalta, Pfizer, Janssen, AbbVie, and Lilly for its ENHANZE drug delivery platform. Halozyme is headquartered in San Diego. For more information, visit www.halozyme.com.
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