FDA approves Teva's version of Amgen's Neupogen

Teva on Thursday said the FDA approved tbo-filgrastim, which is similar to Amgen's Neupogen (filgrastim), to reduce the duration of severe neutropaenia in adults with non-myeloid malignancies treated using chemotherapy drugs that substantially decrease neutrophil production. The company noted that the product is the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the US in over 10 years.

The drugmaker indicated that in the US, where Neupogen faces patent expiration next year, tbo-filgrastim was filed as a biologic application since a biosimilar approval pathway has not yet been established. Earlier this year, the FDA issued draft guidance aimed at assisting pharmaceutical companies with the development of biosimilar products in the US.

The regulator noted that approval was based on a clinical study of 348 adults with advanced breast cancer receiving treatment with chemotherapy. Results showed that patients who took tbo-filgrastim recovered from severe neutropaenia in 1.1 days, compared with 3.8 days for those given placebo. In addition, the safety of Teva's therapy was evaluated in three studies that included 680 adults with breast cancer, lung cancer or non-Hodgkin’s lymphoma who received high-dose chemotherapy. The FDA said that the most common side effect seen in those receiving tbo-filgrastim was bone pain.

Teva noted that it will market tbo-filgrastim in the US as early as November 2013 under a settlement agreement reached with Amgen last year. The deal also covers Teva's version of Amgen's Neulasta (pegfilgrastim). US sales of Neupogen reached $959 million in 2011, while Neulasta generated $3 billion in revenue.

Commenting on the news, RBC Capital Markets analyst Michael Yee said "while approval [of Teva's product] 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." The drugmaker currently markets the therapy in Europe as a biosimilar version of Neupogen under the trade name TevaGrastim, which Yee says currently accounts for about 5 percent of the overall market in the region.

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