Fingolimod Mylan

Fingolimod Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis. Fingolimod Mylan is available as capsules (0.5 mg). The recommended dose for adults is one capsule taken once a day by mouth, the recommended dose for children depends on body weight.

For more information about using Fingolimod Mylan, see the package leaflet or contact your doctor or pharmacist.

The European Medicines Agency concluded that, in accordance with EU requirements, Fingolimod Mylan has been shown to have comparable quality and to be bioequivalent to Gilenya. Therefore, the Agency’s view was that, as for Gilenya, the benefits of Fingolimod Mylan outweigh the identified risks and it can be authorised for use in the EU.

The company that markets Fingolimod Mylan must ensure that all doctors who prescribe the medicine receive an information pack containing important safety information, including a checklist of the risks with Fingolimod Mylan and the situations where its use is not recommended. The checklist includes information on the tests and monitoring in patients before and during treatment with Fingolimod Mylan. The pack will also include a reminder card for patients or their carers with key safety information about Fingolimod Mylan, and a pregnancy-specific card to remind patients that Fingolimod Mylan must not be used during pregnancy and in women who can become pregnant and are not using effective contraception.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fingolimod Mylan have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Fingolimod Mylan are continuously monitored. Suspected side effects reported with Fingolimod Mylan are carefully evaluated and any necessary action taken to protect patients.

Fingolimod Mylan received a marketing authorisation valid throughout the EU on 18 August 2021.

Because Fingolimod Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Gilenya, and do not need to be repeated for Fingolimod Mylan.

As for every medicine, the company provided data on the quality of Fingolimod Mylan. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

In multiple sclerosis, the immune system (the body’s defences) incorrectly attacks the protective sheath around the nerves in the brain and spinal cord. The active substance in Fingolimod Mylan, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis. It does this by blocking the action of a receptor (target) on the T cells called the sphingosine-1- phosphate receptor, which is involved in controlling the movement of these cells in the body.

Fingolimod Mylan was developed as a medicine for treating adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis, a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerves and damages the nerves themselves.

‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods of stable symptoms (remissions). Fingolimod Mylan was to be used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy or is severe and getting worse rapidly.

Fingolimod Mylan contains the active substance fingolimod and was to be available as capsules to take by mouth.

Fingolimod Mylan was developed as a ‘generic medicine’. This means that Fingolimod Mylan contained the same active substance as an authorised ‘reference medicine’ Gilenya and was intended to work in the same way. For more information on generic medicines, see the question-and-answer document here.

Based on the review of the data and the company’s response to the Agency’s questions, at the time of the withdrawal, the Agency had some concerns and its provisional opinion was that Fingolimod Mylan could not have been authorised for the treatment of highly active relapsing remitting multiple sclerosis.

The Agency was concerned that results from the bioequivalence study were not reliable. The time between giving Fingolimod Mylan and Gilenya in turn to the volunteers was not long enough and some of the active substance from the first medicine may have remained in the body before the next one was given. Moreover, the method for measuring the medicine in the blood was not sensitive enough. The Agency’s opinion was that the studies presented did not provide enough evidence on bioequivalence to the reference medicine and Fingolimod Mylan could not be considered a generic medicine of Gilenya.

In addition, the company had not taken sufficient precautions to prevent potentially harmful impurities called nitrosamines from forming during the manufacture of the active substance.

Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Fingolimod Mylan did not outweigh its risks.

Studies on the benefits and risks of the active substance are not needed for a generic medicine because they have already been carried out with the reference medicine. As for every medicine, the company provided studies on the quality of Fingolimod Mylan. It also provided studies to investigate whether Fingolimod Mylan is ‘bioequivalent’ to the reference medicine Gilenya. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

The application was withdrawn after the European Medicines Agency had evaluated the information from the company and prepared questions for the company. After the Agency had assessed the company’s responses to the last round of questions, there were still some unresolved issues.

In its Withdrawal letter: Fingolimod Mylan notifying the Agency of the withdrawal of the application, the company stated that the data provided did not allow conclusions to be drawn on the bioequivalence of the product and an additional bioequivalence study is required.

The company informed the Agency that there are no consequences for patients in clinical trials using Fingolimod Mylan.

If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.