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Teva withdraws US filing for cancer biologic

FDA requests more data for balugrastim

Teva said this week it is "assessing its options" after withdrawing the US drug filing for long-acting white cell stimulator balugrastim.

The Israel-based company said it is in consultation with the US Food and Drug Administration (FDA) on the future of the albumin-fused granulocyte colony stimulating factor (G-CSF) after it became clear that additional data would be needed to support approval.

"The FDA has agreed to work with Teva in designing any additional studies that may be required in support of the BLA [Biologic License Application] for balugrastim," it said in a statement. The drug was being developed to treat reduced white blood cell counts associated with cancer chemotherapy.

The development puts a dent in Teva's bid to launch a portfolio of products to challenge Amgen's G-CSF franchise, represented by short-acting Neupogen (filgrastim) and long-acting Neulasta (pegfilgrastim).

Together, Amgen's two products achieved worldwide sales of $4.83bn in the first nine months of 2013, with Neulasta accounting for $3.29bn of that total. Amgen's US patents for Neupogen expire next month, although the drug is already facing generic competition in Europe and elsewhere.

There was better news for Teva's G-CSF portfolio however after it launched its long-acting G-CSF product Lonquex (lipegfilgrastim) on November 4 in Germany, the first EU market for the drug after its approval in August.

Last year Teva also secured US approval for a short-acting G-CSF called tbo-filgrastim, and launched the drug under the Granix brand name on November 11, marking the "entry of the first new G-CSF to the US market in more than 10 years."

Teva had agreed not to market Granix (formerly known as Neutroval) until November 10 under the terms of a patent dispute settlement with Amgen announced last year. It was approved under a BLA so is not officially a biosimilar of filgrastim.

"With the availability of more G-CSF treatment options, healthcare professionals and their patients with non-myeloid malignancies undergoing myelosuppressive chemotherapy will be able to choose the G-CSF that best suits their needs," commented Lee Schwartzberg, head of haematology and oncology at the University of Tennessee Health Science Centre.

Article by
Phil Taylor

19th November 2013

From: Research

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