Bemfola

follitropin alfa

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This is a summary of the European public assessment report (EPAR) for Bemfola. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Bemfola.

For practical information about using Bemfola, patients should read the package leaflet or contact their doctor or pharmacist.

What is Bemfola and what is it used for?

Bemfola is a medicine that contains the active substance follitropin alfa. It is used to treat the following groups:

  • women who do not produce eggs and who do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
  • women who are undergoing assisted reproductive techniques (fertility treatment) such as in vitro fertilisation. Bemfola is given to stimulate the ovaries to produce more than one egg at a time;
  • women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH). Bemfola is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries;
  • men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease). Bemfola is used together with human chorionic gonadotrophin (hCG) therapy to stimulate sperm production.

Bemfola is a ‘biosimilar medicine’. This means that Bemfola is similar to a biological medicine (also known as the ‘reference medicine’) that is already authorised in the European Union (EU). The reference medicine for Bemfola is GONAL-f.

How is Bemfola used?

Bemfola is available as a solution for injection in a prefilled pen. The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of fertility problems

Bemfola is given by injection under the skin once a day. The dose of Bemfola and how often it is given depend on why it is being used and on the patient’s response to treatment. After the first injection, the patient or their partner may give the injections themselves, if they are well motivated, have been trained and have access to expert advice.

For further information, see the package leaflet.

How does Bemfola work?

The active substance in Bemfola, follitropin alfa, is a copy of the natural hormone FSH. In the body, FSH controls reproductive function: in women, it stimulates the production of eggs in the ovaries; in men, it stimulates the production of sperm in the testicles.

Previously, the FSH used in medicines was extracted from urine. The follitropin alfa in Bemfola, as well as in the reference product GONAL-f, is produced by a method known as ‘recombinant DNA technology’: it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce human FSH.

What benefits of Bemfola have been shown in studies?

Bemfola was compared with GONAL-f in one main study involving 372 women who were undergoing assisted reproductive techniques. The main measure of effectiveness was the number of eggs collected.

Bemfola has been shown to be comparable to the reference medicine, GONAL-f. The study showed that Bemfola was as effective as GONAL-f at stimulating the ovaries during assisted reproductive techniques, as an average of 11 eggs were retrieved with both medicines.

What are the risks associated with Bemfola?

The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with Bemfola, see the package leaflet.

Bemfola must not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients. It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary. It must not be used when it would not be possible for the patient to have an effective response, such as in patients whose ovaries or testicles do not work or in women who should not get pregnant for medical reasons. In women, Bemfola must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina. For the full list of restrictions, see the package leaflet.

In some women, the ovaries can over-respond to stimulation. This is called ‘ovarian hyperstimulation syndrome’. Doctors and patients must be aware of this possibility. For more information, please see the package leaflet.

Why is Bemfola approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Bemfola has been shown to have a comparable quality, safety and effectiveness to GONAL-f. Therefore, the CHMP’s view was that, as for GONAL-f, the benefits of Bemfola outweigh the identified risks. The Committee recommended that Bemfola be given marketing authorisation.

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

A risk management plan has been developed to ensure that Bemfola 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 Bemfola, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Bemfola

The European Commission granted a marketing authorisation valid throughout the European Union for Bemfola on 27 March 2014.

Name Language First published Last updated
Bemfola : EPAR - Summary for the public BG = bălgarski 16/05/2014  
Bemfola : EPAR - Summary for the public ES = español 16/05/2014  
Bemfola : EPAR - Summary for the public CS = čeština 16/05/2014  
Bemfola : EPAR - Summary for the public DA = dansk 16/05/2014  
Bemfola : EPAR - Summary for the public DE = Deutsch 16/05/2014  
Bemfola : EPAR - Summary for the public ET = eesti keel 16/05/2014  
Bemfola : EPAR - Summary for the public EL = elliniká 16/05/2014  
Bemfola : EPAR - Summary for the public EN = English 16/05/2014  
Bemfola : EPAR - Summary for the public FR = français 16/05/2014  
Bemfola : EPAR - Summary for the public IT = italiano 16/05/2014  
Bemfola : EPAR - Summary for the public LV = latviešu valoda 16/05/2014  
Bemfola : EPAR - Summary for the public LT = lietuvių kalba 16/05/2014  
Bemfola : EPAR - Summary for the public HU = magyar 16/05/2014  
Bemfola : EPAR - Summary for the public MT = Malti 16/05/2014  
Bemfola : EPAR - Summary for the public NL = Nederlands 16/05/2014  
Bemfola : EPAR - Summary for the public PL = polski 16/05/2014  
Bemfola : EPAR - Summary for the public PT = português 16/05/2014  
Bemfola : EPAR - Summary for the public RO = română 16/05/2014  
Bemfola : EPAR - Summary for the public SK = slovenčina 16/05/2014  
Bemfola : EPAR - Summary for the public SL = slovenščina 16/05/2014  
Bemfola : EPAR - Summary for the public FI = suomi 16/05/2014  
Bemfola : EPAR - Summary for the public SV = svenska 16/05/2014  
Bemfola : EPAR - Summary for the public HR = Hrvatski 16/05/2014  
Name Language First published Last updated
Bemfola : EPAR - Risk-management-plan summary (English only) 16/05/2014  

This EPAR was last updated on 01/12/2015 .

Authorisation details

Product details

Product details for Bemfola
NameBemfola
Agency product numberEMEA/H/C/002615
Active substance

follitropin alfa

International non-proprietary name (INN) or common name

follitropin alfa

Therapeutic area Anovulation
Anatomical therapeutic chemical (ATC) code G03GA05
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Bemfola
Marketing-authorisation holder

Finox Biotech AG

Revision2
Date of issue of marketing authorisation valid throughout the European Union27/03/2014

Contact address:

Finox Biotec AG
Gewerbestrasse 7
FL-9496 Balzers
Liechtenstein 

Product information

Product information

04/11/2015  Bemfola -EMEA/H/C/002615 -N/0007

Name Language First published Last updated
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015
Bemfola : EPAR - Product Information EN = English 16/05/2014 01/12/2015

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.


Name Language First published Last updated
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014
Bemfola : EPAR - All Authorised presentations EN = English 16/05/2014 22/08/2014

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

In adult women:

  • anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate;
  • stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT);
  • follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l.

In adult men:

  • follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Bemfola : EPAR - Procedural steps taken and scientific information after authorisation EN = English 22/08/2014 01/12/2015

Initial marketing-authorisation documents

Name Language First published Last updated
Bemfola : EPAR - Public assessment report EN = English 16/05/2014 22/07/2014
CHMP summary of positive opinion for Bemfola EN = English 24/01/2014  

Authorised

This medicine is approved for use in the European Union

More information on Bemfola