Subcutaneous rituximab regulatory update

The European Commission approved a subcutaneous formulation of MabThera rituximab from Roche to treat follicular non-Hodgkin's lymphoma (NHL) and diffuse large B cell lymphoma (DLBCL). Roche plans to launch the product in the EU this year. The pharma already markets an IV formulation of the chimeric mAb against CD20 antigen in the EU for NHL, chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA) and DLBCL.

According to Roche, a subcutaneous administration of MabThera takes about 5 minutes instead of about 2.5 hours with the IV administration. The subcutaneous formulation uses Halozyme's Enhanze recombinant human hyaluronidase ( rHuPH20) drug delivery technology. ...