About
This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
- What is Biograstim?
Biograstim is a solution for injection or for infusion (drip into a vein). It contains the active substance filgrastim.
Biograstim is a ‘biosimilar’ medicine. This means that Biograstim is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine’). The reference medicine for Biograstim is Neupogen. For more information on biosimilar medicines, see the question-and-answer document 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 occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);
- to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;
- to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
- to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Biograstim can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
The medicine can only be obtained with a prescription.- How is Biograstim used?
Biograstim is given by injection under the skin or infusion into a vein. How it is given, the dose and the duration of treatment depend on why it is being used, the patient’s body weight and the response to treatment. Biograstim is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately. 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 is made by a bacterium that has received a gene (DNA), which makes it able to
produce filgrastim. The replacement acts in same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.- How has Biograstim been studied?
Biograstim was studied to show that it is comparable to the reference medicine, Neupogen. Biograstim was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer. The study looked at the duration of severe neutropenia during the patients’ first cycle of cytotoxic chemotherapy.
To study the safety of Biograstim, two further studies were carried out in patients with lung cancer and with non-Hodgkin’s lymphoma.
- What benefit has Biograstim shown during the studies?
Treatment with Biograstim and Neupogen brought about similar reductions in duration of severe neutropenia. During the first 21-day chemotherapy cycle, patients treated with either Biograstim or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo. Therefore, the effectiveness of Biograstim was shown to be equivalent to that of Neupogen.
- What is the risk associated with Biograstim?
The most common side effect with Biograstim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones). Other side effects may be seen in more than 1 patient in 10, depending on the condition that Biograstim is being used for. 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) decided that, in accordance with EU requirements, Biograstim has been shown to have a comparable quality, safety and efficacy profile to Neupogen. Therefore, the CHMP’s view was that, as for Neupogen, the benefit outweighs the identified risk. The Committee recommended that Biograstim be given marketing authorisation.
- Other information about Biograstim
The European Commission granted a marketing authorisation valid throughout the EU for Biograstim to CT Arzneimittel GmbH on 15 September 2008.
This EPAR was last updated on 18/08/2011 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
05/08/2011 Biograstim -EMEA/H/C/000826 -II/0010
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Colony stimulating factors
Therapeutic indication
Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Biograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| Biograstim : EPAR - Procedural steps taken and scientific information after authorisation | (English only) | 09/11/2009 | 18/08/2011 |
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Biograstim : EPAR - Public assessment report | (English only) | 29/09/2008 |
Authorised
This medicine is approved for use in the European Union
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