Roche's European Rituximab Sales Drop 11% Due to Biosimilar Competition

Biosimilars have begun to erode sales of Roche’s innovator rituximab (MabThera in Europe, Rituxan in the United States), according to the drug maker’s 2017 annual report.

Roche’s overall European pharmaceuticals sales dropped by 2% in 2017, a decline that Roche says was “mainly due to lower MabThera/Rituxan sales driven by competition from biosimilars.” European sales of MabThera declined by 11% as the innovator drug competed with 2 biosimilar molecules, Celltrion’s product (marketed under 4 names: Blitzima, Ritemvia, Rituzena, and Truxima), and Sandoz’s product (sold as Riximyo).

Also cutting into Roche’s European sales figures was reduced reimbursement for Avastin (bevacizumab), which faces oncoming European and US biosimilar competition from Amgen’s Mvasi. On the horizon is competition for Herceptin (trastuzumab) from Mylan and Biocon’s Ogivri in the United States, as well as from Celltrion’s Herzuma and Samsung Bioepis’ Ontruzant in the European Union.

In the United States, where the originator rituximab does not yet face a biosimilar challenger (though Sandoz and Celltrion have both filed Biologics License Applications for their products with the FDA), overall pharmaceutical sales advanced by 10%. Roche says that increasing sales of Rituxan in the United States were driven by the CD20-targeting drug’s use in immunology indications. In total, MabThera and Rituxan brought in approximately $7.9 billion in worldwide sales in 2017. Overall sales growth in the United States was boosted by the success of 3 additional biologics: Ocrevus (ocrelizumab), Tecentriq (atezolizumab), and Xolair (omalizumab).

As the brand-name rituximab’s sales face further erosion from biosimilar challengers in the days ahead, Roche reports that it is developing 2 new drugs to target CD20, both of which are in phase 1 clinical development. The first is engineered to have 2 antibody fragment regions that bind to CD20 and 1 that binds to CD3 (a protein that plays a role in T-cell activation). The second has a structure with one fragment region binding to CD20 and a second binding to CD3. “These antibodies have the potential to be a long-term differentiator in hematology as they could provide a level of clinical benefit for patients with B-cell malignancies beyond current anti-CD20-targeting antibodies,” according to Roche’s report.

“2018 will be a year of transition: as has long been foreseen, we expect more competition from biosimilars for our cancer medicines MabThera/Rituxan and Herceptin, mainly in Europe, initially,” said Roche’s CEO, Severin Schwan, JD, adding that Roche would focus on developing its portfolio of innovative products as a strategy to regain its marketplace dominance.