ZURICH Switzerland's Novartis increased pressure on Roche's ageing stable of big-selling drugs on Monday by becoming the latest company to win European approval for a cut-price version of Rituxan for blood cancer and immunological diseases.
Rixathon, from Novartis's Sandoz generics unit, follows Celltrion's Truxima that secured the European Commission's blessing in February to be used against diseases including non-Hodgkin's lymphoma and rheumatoid arthritis that are now treated by Roche's Rituxan.
Rituxan, also known as MabThera, racked up 7.3 billion Swiss francs ($7.50 billion) in global sales in 2016 and costs tens of thousands per year.
Novartis is counting on cash-strapped healthcare systems and cost-conscious insurance companies to favor cheaper versions that trials show are as effective. Britain, for example, has set a target for 90 percent of new patients treated in its hospitals to get so-called biosimilars.
"Sandoz is committed to increasing patient access to biologic medicines, and Rixathon will be one of the five major launches we plan in the next four years," Carol Lynch, Sandoz's global head of biopharmaceuticals, said in a statement.
Novartis aims to up the ante later this year by filing for approval of its version of Rituxan in the United States.
Roche's three established blockbusters Rituxan, Herceptin and Avastin, which account for annual sales of 20 billion Swiss francs, all face increasing biosimilar competition by the end of the decade as their patents expire.
Analysts said the first wave of copycats now hitting the market, including Novartis's Rixathon and Celltrion's Truxima, signal stormy weather for Roche.
"We expect biosimilar competition in Europe to impact Roche’s portfolio stronger than expected by the market," wrote Bruno Bulic, an analyst at Baader Helvea, in a note to investors.
More competition is on the way, he said: The European Medicines Agency has five biosimilar Rituxan applications and four Herceptin applications to review.
Roche Chief Executive Officer Severin Schwan has said he believes his company's new medicines including multiple sclerosis drug Ocrevus, which won U.S. approval in March, will help it continue to grow sales, even with the increasing biosimilar incursion.
With Rixathon, Sandoz now has four biosimilars approved in Europe.
($1 = 0.9739 Swiss francs)
(Reporting by John Miller; Editing by Himani Sarkar and Mark Potter)