By Michael Fitzhugh
Teva (NYSE:TEVA) has begun testing a monoclonal antibody designed to mimic Rituxan, Roche's (OTCQX:RHHBY) multi-billion dollar arthritis and cancer medicine. Results of the test, a potentially significant step in stealing market share from Rituxan, are expected in August 2011. If approved, TL011, the experimental drug, could become the first biosimilar marketed in the United States by Teva, which has partnered with the Swiss drug ingredient maker Lonza (OTCPK:LZAGF) on the project.
Rituxan delivered $5.7 billion in global sales during 2009 for Roche and its partner Biogen, which sell the drug as a treatment for non-Hodgkin's lymphoma and chronic lymphocytic leukemia in addition to arthritis. Patent protections for Rituxan won't begin to expire in the U.S. until 2015.
Teva's $5 billion March acquisition of Ratiopharm, Germany's second largest generic drugmaker, provided it with significant new biosimilar development capabilities says Teva's president and CEO Shlomo Yanai.
Teva expects its joint venture with Lonza, established in January 2009, to help it establish a position in the forefront of the emerging biosimilars field by developing, manufacturing and marketing a portfolio of biosimilars.
Biosimilars is an “important future growth engine” for the company, Yanai told investors during the company's most recent earnings call.
In February, the FDA accepted Teva's application for approval of XM02, a biosimilar for Amgen's (NASDAQ:AMGN) Neupogen. That drug has already been approved in Europe, where it is sold as TevaGrastim.