FDA approves TEVA version of filgrastim

September 3, 2012 5:59 AM

Teva Pharmaceutical Industries Ltd. announced on Thursday that the U.S. Food and Drug Administration (FDA) has granted approval for tbo-filgrastim, the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years.

Tbo-filgrastim is a short-acting recombinant form of G-CSF, indicated to reduce the duration of severe neutropenia in patients with certain types of cancer (non-myeloid malignancies) who are receiving chemotherapy that affects the bone marrow. Neutropenia is a condition in which the number of white blood cells is decreased, leaving patients more susceptible to potentially life-threatening bacterial infections.

Teva currently markets filgrastim in Europe under the trade name Tevagrastim®, a biosimilar to Neupogen®. Tbo-filgrastim was filed in the U.S. as a Biologics License Application (BLA) since a biosimilar approval pathway had not been established at the time of submission. Teva will market tbo-filgrastim as early as November 2013, in accordance with the settlement reached with Amgen.

“As a company dedicated to bringing needed medicines to patients, we are delighted with the approval of tbo-filgrastim which offers physicians and their patients undergoing chemotherapy a new supportive care treatment option,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd. “The approval of tbo-filgrastim demonstrates Teva’s strong commitment to providing patients with new treatment options. It expands upon Teva’s existing Oncology portfolio with the addition of the first biologic and supportive care agent for oncology patients.”

In studies of tbo-filgrastim, the drug was shown to have statistically significant reductions in the duration of severe neutropenia compared to placebo. During the first 21-day chemotherapy cycle, patients treated with tbo-filgrastim had severe neutropenia for an average of 1.1 days, compared with 3.8 days for those receiving placebo.

 

Editor’s note: It should be noted once again that the product will be marketed in November 2013, which means that US patients has still time to reach a filgrastim biosimilar.

Source: Teva Pharmaceuticals

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)


Latest News on Biosimilar News

Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?

Suggestions?

Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!