The U.S. Food and Drug Administration has approved Mylan‘s generic version of AstraZeneca‘s Faslodex injection to be used for the same breast cancer indications as the original product, the company announced.
The approval makes Mylan‘s Fulvestrant injection the third generic version of Faslodex, following the approval of Sandoz‘s and Glenmark Pharmaceuticals‘ products.
A generic version of a therapy contains the same active chemical substance as an approved brand-name drug and, therefore, has the same medical profile with regards to dosage, safety, manner of administration, and performance. However, generics are usually sold at significantly lower prices than the original product, making treatments accessible to more patients.
“Mylan’s launch of Fulvestrant Injection represents an important addition to our growing oncology portfolio and, more importantly, expands the available treatment options for women who are facing advanced or metastatic stages of breast cancer,” Rajiv Malik, president of Mylan, said in a press release.
“The launch also reinforces our scientific expertise in bringing to market complex products, like injectables, which further enhances our institutional business and exemplifies our continued commitment to expanding access to medicine,” he added.
Most breast cancers are positive for hormone receptors (HR), which means they depend on hormones, such as estrogen, to continue growing.
Faslodex is a form of hormone therapy that prevents estrogen from interacting with its receptor, reducing the growing signals to the tumors. It was first approved by the FDA in 2002 for the treatment of postmenopausal women whose disease progressed after being treated with an anti-estrogen therapy, such as tamoxifen.
Later on, the treatment became available for postmenopausal women with HR-positive advanced breast cancer who had not received prior hormone therapy.
Additional indications now include Faslodex as an add-on treatment to Kisqali (ribociclib) for women with HR-positive breast tumors whose cancer has spread to other parts of the body. This combination may be given as a first-line hormone therapy or to women whose disease has worsened following hormone therapy.
Faslodex is also approved in combination with either Ibrance (palbociclib) or Verzenio (abemaciclib) for women with advanced or metastatic HR-positive breast tumors who have failed prior hormone therapy.
Mylan’s Fulvestrant injection will be available for the same indications as Faslodex and will be marketed as a prefilled syringe containing 250 mg of fulvestrant in 5 mL.