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12:00 AM
Oct 22, 2012
 |  BioCentury  |  Strategy

Race for rituximab

Beyond price: Rituximab biosimilar race hinges global commercial skills

If all 11 planned rituximab biosimilars make it to the market, price will determine the winner. But Novartis AG's Sandoz Ltd. unit expects that fewer than half will get to the finish line, and that means price will be only part of the equation.

Rituximab's blockbuster sales and upcoming patent expirations have made it a popular target for biosimilars companies.

Rituxan/MabThera is a $6.5 billion drug for partners Biogen Idec Inc. and Roche's Genentech Inc. unit. The chimeric mAb against CD20 is approved in the U.S. and EU to treat non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) and rheumatoid arthritis (RA). It is also approved in the EU to treat diffuse large B cell lymphoma (DLBCL).

The patents expire between 2015 and 2018 in the U.S. and next year in the rest of the world.

Dr. Reddy's Laboratories Ltd. launched its biosimilar version of rituximab as Reditux to treat NHL in India in 2007. The company would not comment on its plans to develop and market Reditux elsewhere.

At least seven other biosimilars are in the clinic, and there are four more for which the development status is undisclosed (see "Targeting Rituximab").

Although Teva Pharmaceutical Industries Ltd. halted its clinical program this month and Samsung Group stopped its trial at some sites, companies like Sandoz are moving forward.

According to the EU Clinical Trials Register, Samsung's Phase III trial of SAIT101 for RA was halted in the Czech Republic and Spain, but is continuing in the U.K., Hungary and Poland.

Samsung did not respond to BioCentury's request for information on the decision to halt the trial in those countries.

While the Korean conglomerate has committed to invest nearly $2 billion into developing biosimilars over 10 years and has entered JVs with Quintiles Transnational Corp. and Biogen, it is a newcomer to biopharmaceuticals (see BioCentury, Dec. 19, 2011).

Rituximab was the company's only disclosed...

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