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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/272719/2016

EMEA/H/C/000727

EPAR summary for the public

Abseamed

epoetin alfa

This is a summary of the European public assessment report (EPAR) for Abseamed. 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 Abseamed.

What is Abseamed?

Abseamed is a solution for injection. It is available in pre-filled syringes that contain between 1,000 and 40,000 international units (IU) of the active substance, epoetin alfa.

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

What is Abseamed used for?

Abseamed is used for the following:

•    to treat anaemia (low red blood cell counts) that is causing symptoms in patients with 'chronic kidney failure' (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;

•    to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions;

•    to increase the amount of blood that can be taken in adult patients with moderate anaemia and normal blood iron levels who are going to have an operation and donate their own blood before surgery (autologous blood transfusion);

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• to reduce the need for blood transfusions in adults with moderate anaemia who are about to

undergo major orthopaedic (bone) surgery, such as hip surgery. It is used in patients with normal blood iron levels who could experience complications if they were to receive a blood transfusion, if they do not have the opportunity to donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood.

The medicine can only be obtained with a prescription.

How is Abseamed used?

Treatment with Abseamed must be started under the supervision of a doctor who has experience in the management of patients with the conditions that the medicine is used for. The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.

Abseamed is given as an injection into a vein or as an injection under the skin, depending on the condition for which the patient is being treated. The injection under the skin may be given by the patient or their carer if they have been appropriately trained. The dose, the frequency of injection and how long it is used for also depend on why Abseamed is being used and on the patient's bodyweight, and are adjusted according to the patient's response.

For patients with chronic kidney failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children). Haemoglobin is the protein in red blood cells that carries oxygen around the body. For these patients, the lowest dose that provides adequate control of symptoms should be used.

For full details, see the summary of product characteristics (also part of the EPAR).

How does Abseamed work?

The active substance in Abseamed, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells from the bone marrow. Erythropoietin is produced by the kidneys. In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally. In these cases, epoetin alfa is used to replace the missing hormone or to increase red blood cell counts. Epoetin alfa is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.

How has Abseamed been studied?

Abseamed was studied to show that it is comparable to the reference medicine, Eprex/Erypo. Abseamed, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems. All of the patients had been receiving Eprex/Erypo injected into a vein for at least eight weeks before they were either switched to Abseamed or remained on Eprex/Erypo. The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29. The company also presented the results of a study comparing the effects of Abseamed injected under the skin with those of Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.

A further study looked at the effects of Abseamed given under the skin in 416 patients with chronic kidney failure.

Abseamed

What benefit has Abseamed shown during the studies?

Abseamed was as effective as Eprex/Erypo in increasing and maintaining red blood cell counts.

In the study of patients with anaemia caused by kidney problems, patients switching to Abseamed maintained haemoglobin levels to the same extent as those continuing to take Eprex/Erypo. The study in patients receiving chemotherapy showed that Abseamed was also as effective as Eprex/Erypo when it was injected under the skin.

The study in patients with chronic kidney failure showed that Abseamed was safe and effective when given under the skin.

What is the risk associated with Abseamed?

The most common side effects with Abseamed (seen in more than 1 patient in 10) are nausea (feeling sick), diarrhoea, vomiting, pyrexia (fever) and headache. Flu-like illness may occur especially at the start of treatment. For the full list of all side effects reported with Abseamed, see the package leaflet.

Abseamed must not be used in the following groups:

•    patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin;

•    patients with high blood pressure that is not controlled;

•    patients undergoing surgery who cannot receive medicines for the prevention of blood clots.

•    When Abseamed is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.

•    It must also not be used in patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.

For the full list of restrictions, see the package leaflet.

Why has Abseamed been approved?

The CHMP concluded that, in accordance with EU requirements, Abseamed has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo. Therefore, the CHMP's view was that, as for Eprex/Erypo, the benefit outweighs the identified risks. The Committee recommended that Abseamed be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Abseamed?

A risk management plan has been developed to ensure that Abseamed is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abseamed, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Abseamed

The European Commission granted a marketing authorisation valid throughout the European Union for Abseamed on 28 August 2007.

Abseamed

The full EPAR for Abseamed can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Abseamed, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2016.

Abseamed

EMA/272719/2016

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