Roche Gets New EU Approval for MabThera

Approval for a rare autoimmune disorder may help company fight declining sales in face of biosimilar competition.

 MabThera, known as Rituxan in the United States, is a leading product for Roche, but it faces significant competition from biosimilars and a measurable decline in sales. 

A new approval from the European Commission for MabThera for the treatment of moderate to severe cases of pemphigus vulgaris, a rare skin blistering disease currently treated by corticosteroids, could help the company boost those declining sales. The approval is the first for a drug to treat this disease in 60 years, and over 50,000 people in Europe suffer from pemphigus vulgaris, according to Roche.

The U.S. Food and Drug Administrated had granted priority review, breakthrough therapy and orphan drug designations and approved Rituxan in June 2018. With the EC approval, MabThera has EU approvals for the treatment of four autoimmune diseases and three types of blood cancer. Even so, its global sales fell by 7% in 2018, down to $6.7 billion from $7.3 billion in 2017. The greatest decline occurred in Europe, where biosimilars are becoming widely adopted, though some of those losses were offset by increasing penetration into the Chinese market.


The EC decision was based on the results of a phase III study of MabThera in combination with a tapering regimen of oral corticosteroid (CS), which showed the therapy helped a large percentage of patients achieve complete remission in 24 months, compared with CS alone (89.5% versus 27.8%).

David Alvaro, Ph.D.

David is Scientific Editorial Director for That’s Nice and the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University and a Ph.D. in Genetics and Development from Columbia University.

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