FDA Accepts Genentech's BLA for Subcutaneous Formulation of Rituximab

Halozyme Therapeutics has announced that the U.S. Food and Drug Administration (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 U.S.

"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 health care practitioners."  

Including all approved indications, Roche reported total 2015 sales of rituximab in the United States of 3.76 billion CHF.

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