EMA, Regulatory

Roche clinches EU approval for MabThera in rare autoimmune indication — will it boost dwindling sales amid biosimiar competition?

Roche is piling up another European approval for its MabThera franchise just as biosimilars are seriously eroding sales of the crucial drug, better known in the US as Rituxan.

The European Commission handed the OK for moderate to severe cases of pemphigus vulgaris, a rare skin blistering disease currently treated by corticosteroids. This is an indication where Roche swept the priority review, breakthrough therapy and orphan drug designations before nabbing the FDA approval last June — and one which hasn’t seen a new treatment option in 60 years, according to the company.

Sandra Horning, Roche CMO, at an Endpoints News event during #JPM19 in San Francisco, January 2019 Endpoints News


It remains to be seen how much an expanded label — now covering four autoimmune diseases and three types of blood cancer — can plug the sizable hole in MabThera’s revenue drain.

In 2018, global sales of the drug fell by 8% to $6.7 billion from 2017’s $7.3 billion, largely driven by a 47% plunge in Europe attributed to competition from biosimilars but offset by considerable market penetration in China and a modest growth in the US.

More than 50,000 people in Europe currently suffer from pemphigus vulgaris, Roche CMO Sandra Horning said in a statement.

“This MabThera approval provides a much needed new treatment that has been shown to provide higher remission rates than corticosteroids alone, which can cause debilitating side effects,” she added.

In the Phase III Ritux 3 trial, a combo of MabThera with a tapering regimen of oral corticosteroids was shown to help a larger percentage of patients achieve complete remission in 24 months than CS alone (89.5% versus 27.8%).

Roche is sponsoring another ongoing study to compare Mabthera with mycophenolate mofetil, an immunosuppressant, in the same spectrum of PV patients.


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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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