Generic drug giant Teva Pharmaceutical says it has applied to the U.S. Food and Drug Administration for approval to market its own version of Amgen's wide-selling Neupogen, which is used to help combat neutropenia. Dubbed XM02, Teva's therapeutic is already sold in the European Union as TevaGrastim and has been shown to reduce the duration of severe neutropenia, in which a patients' bone marrow fails to make enough white blood cells when treated with a certain type of chemotherapy.

 

Sales of Amgen's Neupogen hit approximately $1.3 billion worldwide, according to IMS Health data shared by Teva. To head off any legal objections from Amgen, the Israeli generics company has preemptively sued the California giant, seeking to establish that XM02 does not infringe on any Neupogen-related patents.

 

Because Teva's XM02 application is using a Biologics License Application, which is for new drugs, and comes before the FDA has fully laid out a path to approval for biosimilars, the company is keen on tightly coordinating with regulatory authorities.

 

"We look forward to working closely with the FDA to bring this important treatment option to the U.S.,” says William Marth, president and CEO of Teva North America.