Teva’s Version of Neupogen Approved by FDA

The US FDA (Food and Drug Administration) have approved Teva Pharmaceutical Industries’ form of Amgen’s severe neutropenia therapy, Neupogen.

The FDA have approved tbo-filgrastim, which Teva noted is the first new granulocyte colony-stimulating factor (G-CSF) to be backed by the US agency in over 10 years.  The drug is a copy of Neupogen (filgrastim), which the organisation currently sells in Europe as Tevagrastim.  The Israeli company explained that the medication was submitted in the US as a Biologics License Application “since a biosimilar approval pathway had not been established at the time of submission.”

Tbo-filgrastim increases the production of infection-fighting white blood cells in some cancer patients who are receiving chemotherapy.

Tbo-filgrastim will be marketed in the USA as soon as November 2013, in accordance with the agreement arranged with Amgen.  The drug is proposed for use in adults who have cancers except blood or bone marrow cancers (i.e. non-myeloid malignancies) and are taking chemotherapy drugs that result in a substantial decrease in the production of neutrophils in the bone marrow.

Amgen’s U.S. sales of Neupogen were $959 million last year, while sales of Neulasta were $3 billion.  Amgen’s Neupogen, faces the termination of its US patent next year.

Tbo-filgrastim was evaluated in a clinical trial of 348 adults with advanced breast cancer receiving treatment with doxorubicin and docetaxel.  The drug’s safety was studied in three trials composed of 680 adults with breast cancer, lung cancer or non-Hodgkin’s lymphoma who received high-dose chemotherapy that reduces bone marrow cells.

“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 commented in a research note.


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