Teva halts the Phase III studies of biosimilar rituximab

October 5, 2012 8:15 AM

rituxan mabthera Teva halts the Phase III studies of biosimilar rituximab

Teva, the Israeli pharmaceuticals company has stopped the clinical trial of their rituximab version. Three years after Teva and Lonza, the Swiss biopharmaceutical company, collaboration one of their leading development programs has finished unexpectedly.

The Israeli newspaper, Haaretz reports that, the Phase III trial was halted recently. According to the report, the pharmaceutical giant has suspended the Phase III testing of its biosimilar version of the $7 billion a year drug Rituxan, used in the treatment of certain types of cancer and rheumatoid arthritis.

Rituxan (Mabthera outside US) is used in the treatment of cancers such as chronic lymphocytic leukemia and non-Hodgkin lymphoma, as well as rheumatoid arthritis. Sandoz, Teva and Celltrion were the leading companies which are working on biosimilar versions of the drug.

Roche (and Genentech), secured global patent protection until the end of 2013, with the exception of the U.S., where the drug is protected from competition until 2018, the company has said. It is Roche’s best-selling drug: Sales reached 3.3 billion Swiss francs in the first half of 2012, an increase of 8.4% from the same period of the year before. That works out to about $7.1 billion a year in sales.

Developing a biosimilar version of rituximab is a key goal of the joint venture that Teva, the biggest generic drugmaker in the world, formed in January 2009 with the Swiss company Lonza.

Suspending Phase III clinical testing of the biosimilar version puts the venture behind rivals Sandoz and Celltrion, which are forging ahead with Phase III tests for oncological indications. The two companies are expected to announce the results of their tests during in the first quarter of 2013. Assuming success, the companies are expected to receive marketing approval for their copycat version of Rituxan/Mabthera in the last quarter of 2014.

Source: Haaretz

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