o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/201987/2010

EMEA/H/C/1142

EPAR summary for the public

Nivestim

filgrastim

This document is a summary of the European Public Assessment Report (EPAR) for Nivestim. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nivestim.

What is Nivestim?

Nivestim is a solution for injection or infusion (drip into a vein) that contains the active substance filgrastim. It is available as prefilled syringes (12, 30 or 48 million units).

Nivestim is a 'biosimilar' medicine. This means that Nivestim is similar to a biological medicine (the 'reference medicine') that is already authorised in the European Union (EU) and contains the same active substance as the reference medicine. The reference medicine for Nivestim is Neupogen. For more information on biosimilar medicines, see the question-and-answer document here.

What is Nivestim used for?

Nivestim 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 (medicines to treat cancer) 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 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;

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

• 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.

Nivestim can also be used in people 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 Nivestim used?

Nivestim 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. Nivestim 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 Nivestim work?

The active substance in Nivestim, 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 the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.

How has Nivestim been studied?

Nivestim was studied to show that it is comparable to the reference medicine, Neupogen. Nivestim was compared with Neupogen in one main study involving 279 women with breast cancer who were being treated with anticancer medicines. The main measure of effectiveness was based on the reduction in the length of time that the patients had severe neutropenia.

What benefit has Nivestim shown during the studies?

Studies carried out with Nivestim showed that it was comparable to Neupogen. In the main study, the patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen.

What is the risk associated with Nivestim?

The most common side effect with Nivestim (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 Nivestim is being used for. For the full list of all side effects reported with Nivestim, see the Package Leaflet.

Nivestim should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.

Why has Nivestim been approved?

The CHMP decided that, in accordance with EU requirements, Nivestim has been shown to have a comparable quality, safety and efficacy profile to Neupogen. Therefore, the CHMP's view was that, as

Nivestim

EMA/201987/2010    Page 2/3

for Neupogen, the benefit outweighs the identified risk. The Committee recommended that Nivestim be given marketing authorisation.

Other information about Nivestim:

The European Commission granted a marketing authorisation valid throughout the EU for Nivestim to Hospira UK Limited on 8 June 2010. The marketing authorisation is valid for five years, after which it can be renewed.

The full EPAR for Nivestim can be found here. For more information about treatment with Nivestim, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2010.

Nivestim

EMA/201987/2010