According to Teva, the FDA has issued a Complete Response Letter to request additional information needed to complete the review of the application for product approval. The letter requested several items which Teva is reviewing and will work with the FDA to determine the appropriate next steps regarding the Neutroval application.

The application for Neutroval, was filed in December 2009 using a traditional approval pathway for a biologic drug (via BLA) and included results from five clinical studies which enrolled more than 680 patients. The FDA has yet to release guidance on the approval pathway for biosimilars, despite provisions for such drugs being included in the US healthcare reform back in March 2010.

The drug was approved in Europe, where a clear biosimilars pathway exists, in September 2008 and is sold under the name TevaGrastim.

Any delay will please Amgen, who have already filed a patent-infringement lawsuit against Teva. Such action by Amgen is not suprising, when considering the combined worldwide sales of Amgen’s Neulasta (pegfilgrastim) and Neupogen (filgrastim), which were US$1,174 million in the second quarter of 2010.

Neupogen is approved for reduction in the duration of severe neutropenia and in the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

Teva, with an 18% market share in 2009, is the world’s largest generics manufacturer.

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References

Teva Press Release. Teva Provides Update on Status of Neutroval™ (G-CSF) Biologics License Application Submitted to the U.S. Food and Drug Administration. 30 September 2010.

Teva Press Release. Teva Announces The Submission Of A Biologics License Application (BLA) For XM02 For The Treatment Of Chemotherapy-Induced Neutropenia. 1 December 2009.

Amgen Press Release. Amgen's Second Quarter 2010 Adjusted Earnings Per Share Increased 7 Percent to $1.38. 29 July 2010.