Neupogen biosimilar already marketed in Europe as Tevagrastim
Teva's biosimilar drug tbo-filgrastim has won US approval to treat certain cancer patients who have an abnormally low number of white blood cells.
The Food and Drug Administration (FDA) said the drug, which is a biosimilar version of Amgen's Neupogen, can be used in patients to hasten recovery from instances of neutropaenia - a condition in which the number of neutrophil white blood cells is decreased, leaving patients more susceptible to bacterial infections.
The approval is for the drug's use in adults who have cancers other than blood or bone marrow cancers and are taking chemotherapy drugs that cause a substantial decrease in the production of neutrophils in the bone marrow.
Tbo-filgrastim, which is manufactured by Teva's subsidiary Sicor Biotech, is already marketed n the Europe under the trade name Tevagrastim. Teva said it intends to launch the product in the US by November 2013.
As the drug is a biosimilar product, Teva had used a biologics license application to apply for marketing approval in the US, although the country has now introduced a biosimilar pathway for such products, and has recently added biosimilar drug user fees in its FDA Safety and Innovation Act (FDASIA).
Despite being a biosimilar of Neupogen, under FDA rules, Teva still had to prove the safety and efficacy of tbo-filgrastim in clinical trials.
The drug was able to demonstrate in a trial involving 348 adult patients with advanced breast cancer receiving the anti-cancer drugs doxorubicin and docetaxel that people receiving tbo-filgrastim recovered from severe neutropaenia in 1.1 days compared with 3.8 days in those receiving a placebo.
In addition, tbo-filgrastim's safety was evaluated in three clinical studies composed of 680 adults with breast cancer, lung cancer, or non-Hodgkin's lymphoma who received high-dose chemotherapy that reduces bone marrow cells. The most common side effect observed was bone pain.
"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.