Novartis scores EU approval for biosim of Roche's blockbuster Rituxan

Novartis HQ
Novartis has won European approval of Rixathon, its biosimilar of Roche's $7.3 billion drug Rituxan.

Roche faces bad news today for its third-top selling drug Rituxan after its cross-town rival Novartis won European approval for its biosimilar, adding to the pressure for the $7.3 billion blockbuster.  

Rixathon, the copy from Novartis’ Sandoz unit, was approved to treat both blood cancers, including non-Hodgkin's lymphoma, and immunological diseases such as rheumatoid arthritis. Sandoz follows Celltrion into the market, which in February won approval of its Rituxan biosimililar, Truxima. 

Carol Lynch, global head of biopharmaceuticals for Sandoz, said the approval gives patients broader access to a life-enhancing drug.

“It also allows healthcare systems to redeploy resources to other areas of high need, particularly innovative therapies," Lynch said, making a direct pitch to Europe’s cash-strapped healthcare systems, while urging them to plow any savings into approvals of new drugs, something they have been slow to do in recent years.

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The biosimilar assault on Rituxan comes 20 years after its 1997 approval. The drug has grown steadily in sales, helped since 2014 by approval of a subcutaneous formulation of the antibody. Rituxan had global sales of $7.3 billion last year, including $1.9 billion in Europe, but with a handful of other competitors targeting the drug in Europe, the U.S. and elsewhere, that will be falling fast over the next few years. Analysts project global Rituxan sales in 2020 to reach about $2.9 billion.  

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For Novartis, Rixathon is the fourth biosimilar approved in Europe and one more step in its is plan to be a dominant player in the the field. It was the first to win approval of a biosimilar in the U.S., and has plans to have 11 biosimilar regulatory filings in the can by the end of this year, including Rixathon in the U.S.

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Biosimilar makers won a huge victory in their efforts in the U.S. just last week when the U.S. Supreme Court ruled that they could give drugmakers marketing notice before FDA approval, meaning their products can launch faster. Amgen, in a battle with Novartis, had argued that notice should have to wait for FDA approval.

But not everything in Novartis' biosimilar effort has gone flawlessly. The company last year had the FDA reject its application for a biosimilar version of Amgen’s blockbuster drug Neulasta because of questions about manufacturing. It then withdrew its application for that drug in the EU.