FDA Approves Teva’s Generic Version of Amgen Drug Neupogen–Drug Given With Chemotherapy That Boosts White Blood Cell
Posted Aug 29 2012 8:49pm
It won’t be available to market in the US though until the patent expires which is November of 2013 so there’s a little more than a year to wait; however n Europe Teva already sells the drug. The drug helps chemotherapy patients recover faster and deals with the side effects of the treatment. Teva also has a generic version of the Amgen drug Neulasta which is a longer lasting version of the first drug and it too has the same date of November of 2013 before marketing in the US. It was back in December of 2009 that Teva asked the FDA for approval of their bio similar drug, so a long haul on this one. BD
(Reuters) - Drug regulators gave the nod to a Teva Pharmaceutical Industries drug that boosts the production of infection-fighting white blood cells in certain cancer patients receiving chemotherapy.
Teva's medicine is similar to Amgen Inc's biologic drug Neupogen, which faces the expiration of its U.S. patent next year.
"While approval at this time is somewhat unexpected, we note the two drugs are not substitutable, and it will require a launch ramp and extensive marketing efforts by Teva to gain share," RBC Capital Markets analyst Michael Yee said in a research note.
Amgen's U.S. sales of Neupogen were $959 million last year, while sales of Neulasta, the biotech company's longer-lasting white blood cell booster, were $3 billion.
"Teva is prohibited by court order from marketing this product in the U.S. prior to November 10, 2013," Amgen said in a statement.