On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s Rituxan®/Mabthera®. The approval follows the positive recommendation by the Committee for Medicinal Products for Human Use (“CHMP”) issued two months ago.
Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. Rixathon® was approved for all indications of the reference product in Europe. According to Sandoz’s announcement, the approval of Rixathon® was based on a comprehensive development program, including analytical, preclinical, and clinical data, demonstrating biosimilarity of Rixathon® to the reference medicine, MabThera®. Sandoz also received approval in the EU for Riximyo®, the company’s other rituximab biosimilar, through a duplicate marketing authorization. Sandoz currently has an application pending for rituximab in Japan, and the company has publicly stated that it expects to submit an application for rituximab to the FDA in 2017.
Rixathon will be Sandoz’s fourth biosimilar with full approval in the EU. Sandoz also received marketing authorization for its biosimilar products related to epoetin alfa, somatropin, and filgrastim in Europe. In addition, Sandoz’s Erelzi®, a proposed biosimilar to Amgen’s Enbrel® (etanercept), recently received a positive recommendation by the CHMP.
Rixathon®/Riximyo® will join Celltrion’s rituximab biosimilar Truxima®, which was approved in the EU in February 2017 as we reported here. Celltrion also received positive recommendations from the CHMP for additional rituximab biosimilars, including Blitzima, Ritemvia, and Tuxella on May 18, 2017. As a result, the EU may soon have a substantial number of rituximab biosimilar drug options.
In stark contrast, the U.S. FDA has not yet approved any rituximab biosimilar products for the U.S. markets. We previously reported on the status of biosimilar authorizations in the U.S. compared to Europe. This recent announcement for Sandoz’s rituximab biosimilar products, which may be followed by a group of rituximab biosimilar products by Celltrion, continues the trend, but hopefully not for long.