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Fulvestrant Mylan (fulvestrant) generic of Faslodex approved by EMA for the Treatment of breast cancer

Fulvestrant Mylan is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women with a type of breast cancer known as ‘oestrogen-receptor positive cancer’ who have not previously had hormonal treatment, or whose cancer had come back after treatment with another anti-oestrogen.

Fulvestrant Mylan contains the active substance fulvestrant.

Fulvestrant Mylan is a ‘generic medicine’. This means that Fulvestrant Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Faslodex.

Most types of breast cancer are stimulated to grow when the hormone oestrogen attaches to targets (receptors) on cancer cells. The active substance in Fulvestrant Mylan, fulvestrant, is an anti-oestrogen. It blocks the receptors for oestrogen on cells and causes the number of oestrogen receptors to fall. As a result, the cancer cells are not stimulated to grow by oestrogen and this slows down the growth of the tumour.

The European Medicines Agency concluded that, in accordance with EU requirements, Fulvestrant Mylan has been shown to be comparable to Faslodex. Therefore, the Agency’s view was that, as for Faslodex, the benefit outweighs the identified risk. The Agency recommended that Fulvestrant Mylan be approved for use in the EU.

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