Despite Rituximab's Promise in Neurology, Roche Focuses on Ocrelizumab

Rituximab, which is approved for the treatment of some cancers and inflammatory conditions, also holds significant promise for patients with neurological diseases.

Long-term rituximab use for the treatment of multiple sclerosis (MS) has been shown to be safe and well tolerated with recurrent administration, and a 2016 retrospective observational study published in Neurology found that patients with relapsing MS who were treated with rituximab could expect to experience 1 relapse every 23 years. The study’s authors suggested that further investigation of rituximab in patients with MS be given high priority for public funding, given the potential for patient benefit and reduction of high MS-related treatment costs. Rituximab has also been demonstrated to have long-lasting clinical benefits in patients with drug-resistant myasthenia gravis, and researchers have suggested that the drug be repurposed for this underserved patient population.

However, Roche, maker of the reference Rituxan/MabThera, has not sought regulatory approval for the drug’s use in neurology indications, perhaps because of its declining sales in the face of biosimilar competition. In the European Union, where biosimilars are already available, the reference biologic saw its sales decline by 16% last quarter.

As its hold on the rituximab market wanes, Roche has focused its efforts on its newer ocrelizumab (Ocrevus), a therapy much like rituximab, and one which carries a price tag of $65,000 per year. The drug maker gained FDA approval for the therapy in treating both relapsing and primary progressive MS in 2017, but news of ocrelizumab’s approval sparked controversy among clinicians. Annette Langer-Gould, MD, of the Los Angeles Medical Center and a former employee of Roche’s Genentech division, is quoted in Health News Review as saying that ocrelizumab is little more than an “expensive, overdosed version of Rituxan,” and a “fake breakthrough…it’s shameless.”

Roche appears to disagree; on Monday, the drug maker announced that it plans to present “the largest body of Ocrevus data presented at a congress to date” at the Seventh Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) later this month.

Patients with MS who hope for eventual relief from the high cost of treatment may still have some cause for optimism, however, as the market for biosimilar MS treatments appears to be heating up. Biotech companies Abzena and UGA Biopharma have announced the joint development of a cell line expressing a biosimilar to an existing treatment for MS. The company did not disclose the reference product, but said that the originator therapeutic earned $1.9 billion in sales in 2016.