With no regulatory pathway in existence for biosimilars, Teva is taking its copycat version of Amgen's Neupogen straight to the FDA with a Biologics License Application. And the agency accepted the BLA, which seeks approval to market the white blood cell booster as Neutroval.
Teva's biologic, XM02, is already sold in Europe, where regulators have established an approval pathway for generic copies of biologics. The therapy is designed to boost the white blood cell count of patients undergoing chemotherapy, which commonly triggers severe neutropenia. Amgen reported worldwide 2009 sales of $4.64 billion for Neupogen and Neulasta, a related drug. Neupogen has long been a mainstay blockbuster for the world's biggest independent biotech company.
Congress had been debating a regulatory pathway for biosimilars, with the House passing a provision allowing for 12 years of data exclusivity. The recent Senate seat election in Massachusetts, which turned Ted Kennedy's old seat over to the Republicans, has thrown that process into turmoil.
- here's the story from Reuters
Correction: This story originally cited worldwide sales of $4.64 billion for Neupogen alone. The figure actually reflects the combined revenue for Neupogen and Neulasta.