What is Biograstim?
Biograstim is a solution for injection or infusion (drip into a vein). Contains the active ingredient filgrastim.
Biograstim is a "biosimilar" medicine, meaning that it is similar to a biological medicine already authorized in the European Union (EU) that contains the same active substance (also called "reference medicine"). The reference medicine for Biograstim is Neupogen. For more information on biosimilar medicines, see the questions and answers by clicking here.
What is Biograstim used for?
Biograstim is used to stimulate the production of white blood cells in the following situations:
• to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the incidence of febrile neutropenia (neutropenia with fever) in patients undergoing chemotherapy (treatment of a tumor) cytotoxic (cell destroyer);
• to reduce the duration of neutropenia in patients undergoing treatment aimed at destroying bone marrow cells before a transplant of the same (as in some leukemic patients) if they are at risk of long-term severe neutropenia;
• to increase neutrophil levels and reduce the risk of infection in patients with neutropenia who have a history of serious and repeated infections;
• to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, in order to reduce the risk of bacterial infections when other treatments are inadequate.
Biograstim can also be used in patients who are about to donate stem cells for a transplant, to help them release these cells from the bone marrow. The medicine can only be obtained with a prescription.
How is Biograstim used?
Biograstim is given by subcutaneous injection or intravenous infusion. How it is administered, the dosage and duration of treatment depend on the reason for its use, the patient's body weight and the response to treatment. Biograstim is generally given in a specialized treatment center, although patients who are injected under the skin can inject it themselves, provided they are properly trained. For more information, see the package leaflet.
How does Biograstim work?
The active substance in Biograstim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). Filgrastim is produced by a method known as "recombinant DNA technology": it derives from a bacterium, in which a gene (DNA) has been grafted which makes it able to produce filgrastim. The substitute acts similarly to the naturally produced G-CSF factor, stimulating the bone marrow to produce more white blood cells.
What studies have been carried out on Biograstim?
Biograstim has undergone studies aimed at demonstrating its similarity to the preparation of
reference, Neupogen. A main study compared Biograstim to Neupogen and a placebo (a dummy treatment) involving 348 breast cancer patients. The study examined the duration of severe neutropenia during the first cycle of cytotoxic chemotherapy in patients. Two other studies were carried out on patients with lung cancer and non-Hodgkin's lymphoma to examine the safety of Biograstim.
What benefit has Biograstim shown during the studies?
Treatment with Biograstim and Neupogen gave almost similar reductions in the duration of severe neutropenia. In the first 21 days of the chemotherapy cycle, patients treated with both Biograstim and Neupogen had on average 1.1 days of severe neutropenia, compared with 3.8 days of those treated with placebo. Therefore, the efficacy of Biograstim proved to be equivalent to that of Neupogen.
What is the risk associated with Biograstim?
The most common side effect seen with Biograstim (in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). In more than one in 10 patients other side effects can be observed, depending on the disease for which Biograstim is used. For the full list of all side effects reported with Biograstim, see the Package Leaflet. Biograstim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Why has Biograstim been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that, according to the provisions of the European Union regulations, Biograstim demonstrated quality, safety and efficacy characteristics similar to those of Neupogen. The CHMP is therefore of the opinion that, as in the case of Neupogen, the benefits outweigh the identified risks. The Committee recommended that Biograstim be given marketing authorization.
More information on Biograstim
On 15 September 2008, the European Commission granted Biograstim a marketing authorization valid throughout the European Union to CT Arzneimittel GmbH.
For the full EPAR of Biograstim, click here.
Last update of this summary: 09-2008.
