Fulphila

Fulphila can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders. It is available as a prefilled syringe containing a solution for injection under the skin. Fulphila is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines). Patients can inject themselves if they have been trained appropriately.

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

Laboratory studies comparing Fulphila with Neulasta have shown that the active substance in Fulphila is highly similar to that in Neulasta in terms of structure, purity and biological activity. Studies have also shown that giving Fulphila produces similar levels of the active substance in the body to giving Neulasta.

In addition, a study involving 194 patients who had chemotherapy before or after surgery for breast cancer showed that Fulphila was as effective as Neulasta in reducing the duration of neutropenia. Neutropenia lasted 1 day on average with both medicines.

Because Fulphila is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Fulphila.

The safety of Fulphila has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta. The most common side effect with Fulphila (which may affect more than 1 in 10 people) is pain in the bones. Pain in muscles is also common. For the full list of side effects and restrictions with Fulphila, see the package leaflet.

The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Fulphila has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way. In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Fulphila is equivalent to that of Neulasta in reducing the duration of neutropenia.

All these data were considered sufficient to conclude that Fulphila will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses. Therefore, the Agency’s view was that, as for Neulasta, the benefit of Fulphila outweighs the identified risk and it can be authorised for use in the EU.

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

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

Fulphila received a marketing authorisation valid throughout the EU on 20 November 2018.

Fulphila is a medicine that contains the active substance pegfilgrastim. It was to be available as a solution for injection under the skin.

Fulphila was developed as a 'biosimilar' medicine. This means that Fulphila was intended to be highly similar to a biological medicine already authorised in the European Union (the 'reference medicine') called Neulasta.

Fulphila was to be used in cancer patients to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and the occurrence of febrile neutropenia (neutropenia with fever).

Neutropenia is a side effect of certain cancer treatments and can lead to development of serious infections.

The company presented results of studies designed to show that Fulphila is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine. In addition, one study in 194 patients receiving cancer medicines compared the safety, effectiveness and immunogenicity, meaning the medicine's ability to trigger the production of antibodies, of Fulphila and Neulasta.

The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions. The CHMP was assessing the company's responses to the questions at the time of the withdrawal.

Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Fulphila could not have been approved to reduce neutropenia in patients taking cancer treatments.

One of the CHMP's main concerns was the lack of a certificate of Good Manufacturing Practice (GMP) for the manufacturing site of the product. Other concerns related to the description of the manufacturing process, the control of impurities in the active substance and the sterilisation of the final product.

Therefore, at the time of the withdrawal, the CHMP was of the opinion that the quality of Fulphila had not been demonstrated.

In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because a GMP certificate for the manufacturing site of Fulphila could not be obtained in the time available.

The company informed the CHMP that the withdrawal does not impact ongoing clinical trials with Fulphila.

If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.

• Biosimilar medicines

A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

The active substance in Fulphila and Neulasta, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol). Filgrastim is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF). It encourages the bone marrow to produce more neutrophils and improves the patient's ability to fight off infections.

Because filgrastim is pegylated, its removal from the body is slowed down, allowing the medicine to be given less often.