Teva to Commercialize a Biosimilar Monoclonal Antibody: Let the Games Begin!!
It was only a matter of time before some company decided to attempt to commercialize a generic version of a therapeutic monoclonal antibody (MAb). The main barrier to entry to the biosimilar MAb market was the patent expiry dates for the first generation of therapeutic MAbs (most were commercialized in the early 1990s and have patent protection until 2018 or longer). The recent health-care overhaul law signed by President Barack Obama earlier this year permits U.S. regulators to approve biosimilar versions of branded biologic drugs and paves the way for commercialization of biosimilar MAbs (and other biologics) in the US.
This past Monday Teva Pharmaceuticals, the world’s largest generic prescription drug manufacturer, announced its plans to commercialize a generic version of Rituxan (rituximab), Roche’s blockbuster MAb used to treat rheumatoid arthritis, leukemia and certain forms of non-Hodgkin lymphoma. Rituxan has patent protection in the U.S. until 2018 and in the rest of the world through 2013. According to the announcement, Teva joined worked with the biomanufacturing giant Lonza to produce sufficient quantities of generic Rituxan for clinical development.
Earlier this month Teva began recruiting patients with rheumatoid arthritis for a clinical trial comparing its biosimilar copy, TL011, with the Roche drug, sold outside the U.S. as MabThera. Teva and Lonza are focusing on monoclonal antibodies, and aim to gain regulatory approval for their first product by the end of 2014 said a Lonza spokesman.
Rituxan generated $5.24 billion in sales last year. Indian generic-drug maker Dr. Reddy’s Laboratories Ltd. began selling a new version of Rituxan in India in 2007 which had $4.2 million in sales in 2009. Interestingly, the size of the biosimilar MAb market is predicted to be much larger than that for therapeutic proteins like Epogen, Neupogen, Avonex and other therapeutically-active proteins.
What will be the next branded MAb-based product to succumb to the biosimilar encroachment? Only time will tell.....
Until next time...
Good Luck and Good Job Hunting!!!!!!!!!!
Abbott Laboratories
Johnson & Johnson (JNJ) is trying to regain sole marketing rights to Remicade, its lucrative anti-TNF treatment for arthritis and psoriasis, because Schering Plough (SGP)—which has most of the marketing rights to the drug outside of the US—is being acquired by Merck. JNJ is seeking arbitration to determine whether or not Centocor, its subsidiary that manufactures Remicade and Simponi, can terminate a marketing agreement for the two drugs—based on terms stipulated in the original contract —if there is a “change of control” at SGP.
Monoclonal antibodies (MAbs)