Generic Fulvestrant Injection Launched for Breast Cancer Monotherapy in Post-Menopausal Women

Amneal has announced the launch of fulvestrant injection, an AO-rated generic equivalent for the reference product fulvestrant (Faslodex, AstraZeneca) injection, in a dosage strength of 250 mg/5 ml (50 mg/ml) per single-dose prefilled syringe.

Fulvestrant injection is used as a monotherapy to treat certain types of breast cancer in post-menopausal women who were not previously treated with endocrine therapy, and as a combination therapy for advanced or metastatic breast cancer in women with disease progression after endocrine therapy.

Faslodex is used in advanced treatment after other endocrine therapies have failed and is available as two 250-mg prefilled syringes. The dose is given as 250 mg/5 mL intramuscular injections, 1 in each buttock, 2 weeks apart, and then monthly afterward.

In two studies presented at the ESMO Congress 2019 earlier last week, known as MONARCH 2 and MONALEESA-3, treatment with a CDK4/6 inhibitor plus fulvestrant was found to improve overall survival in women with hormone receptor-positive, human epidermal growth factor 2-negative advanced breast cancer.

The trials included various patient populations as well as different CDK4/6 inhibitors used as multiple lines of therapy: MONARCH 2 evaluated abemaciclib (Verzenio) plus fulvestrant in patients with advanced breast cancer after failure of endocrine therapy and regardless of menopausal status; the MONALEESA-3 study investigated ribociclib (Kisqali) plus fulvestrant as first- or second-line only in postmenopausal patients.

Faslodex and its generic equivalents had a US market value of approximately $552 million for the 12 months ended August 31, 2019 according to IQVIA.

Reference

• Amneal launches generic for Faslodex® injection [press release]. Amneal. Published October 1, 2019. Accessed October 1, 2019.