FDA Has Accepted Genentech’s BLA for Subcutaneous Rituximab

The FDA has accepted Genentech’s BLA for a subcutaneous formulation of rituximab.  The drug is indicated to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, moderate to severe rheumatoid arthritis, Wegener’s granulomatosis and microscopic polyangiitis.  According to Genentech, its formulation uses a recombinant human hyaluronidase enzyme from Halozyme, approved and marketed under MabThera® outside the U.S.

Stay tuned to the Big Molecule Watch for additional developments.