Roche keeps Rituxan evergreen with Breakthrough designation, new formulation

Roche is finding new ways to keep its oncology and rheumatoid arthritis blockbuster Rituximab/MabThera (rituximab) a big seller, despite the imminent arrival of biosimilar competition in Europe and the US.

The drug is one of the company’s biggest selling cancer drugs, earning 7.3 billion swiss francs ($7.32bn) in 2016, but the first biosimilar version, Celltrion’s Truxima, was approved in Europe last month.

Last week, the company achieved a highly valuable Breakthrough Therapy designation (BTD) in a brand new indication: pemphigus vulgaris, a rare, serious and life-threatening condition characterised by progressive painful blistering of the skin and mucous membranes.

Very few companies have succeeding in gaining BTD status for existing drugs, and if approved, this new orphan drug licence will help prop up revenues.

Then yesterday, the FDA’s oncologic drugs advisory committee recommended approval of rituximab in a new subcutaneous formulation in a range of lymphomas and chronic lymphocytic leukemia.

The new formulation will help cut the time and cost of administering the drug, and make it a convenient - but more expensive - alternative to the coming biosimilar versions of the infused formulation.

“Subcutaneous rituximab can be administered in five to seven minutes compared to an hour and a half or more for intravenous Rituxan,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development.

“The significant reduction in administration time could especially benefit people with blood cancer who may receive years of treatment, and we are pleased the committee unanimously supported this new co-formulation.”

The FDA is expected to make a decision on approval by 26 June, and the subcutaneous version has already been approved in Europe.

Maintaining a healthy Rituxan/MabThera will help Roche sustain its revenues as it brings new products on stream – including its major new multiple sclerosis drug Ocrevus, which gained FDA approval yesterday.