Application to EU withdrawn for Fulphila (pegfilgrastim biosimilar) in neutropenia.- Mylan.

Mylan notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fulphila (pegfilgrastim biosimilar), for reducing neutropenia in patients taking cancer treatments. 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.

As part of the application, 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.