Teva Pharmaceutical is taking aim at Roche's blockbuster Rituxan, confirming reports that it is developing a biosimilar of the monoclonal antibody. Bloomberg reports that Teva appears to be on track to develop the first monoclonal antibody follow-on, one of the pioneers in a coming wave of biosimilars that is expected to start gaining approval around 2013 and 2014.
Teva is studying TL011 as a replacement biologic for rheumatoid arthritis patients now on Rituxan. The therapy, Roche's second top-selling therapy, is also used to treat cancer. Teva is working on biosimilars with Lonza, and Lonza spokesman Michael Frizberg told Bloomberg that the companies plan to start seeking their first approvals for follow-on antibodies in late 2014.
A number of major developers have ambitious plans to develop biosimilars for the U.S. market. And many got started before the new federal law created a regulatory pathway for complex new biologics that can work similarly to approved therapies. Some analysts estimate the market for biosimilars in the U.S. will hit $10 billion over the coming decade. But developers will need to mount new and expensive trials to provide a full set of late-stage data for regulators to review. This market won't look anything like the generic drug industry, where the cost of entry is low and regulatory demands relatively simple.
- here's the article from Bloomberg