Sandoz launches Fulvestrant Injection, the first generic version of FASLODEX®, in the US
May 29, 2019
Princeton, New Jersey, May 30, 2019 – Sandoz today announced that the first generic Fulvestrant Injection has been approved by the US Food and Drug Administration (FDA) and is immediately available in the US. It is a fully substitutable AP rated generic version of AstraZeneca’s FASLODEX®* (fulvestrant) Injection.
This hormonal therapy medicine is recommended for the three quarters of women with advanced breast cancer whose tumor expresses the estrogen receptor (ER), and slows tumor growth by binding to and blocking the ER, a key driver of disease progression1.
“Fulvestrant is an important treatment option for women with advanced breast cancer and we will work to help those in the US who need this critical therapy have access to it at an affordable price,” said Carol Lynch, President of Sandoz Inc. “This treatment fits well with our ongoing strategic focus on oncology, where Sandoz has substantial experience bringing important oncology medicines to hospitals, clinics, doctor’s offices and patients in the US.”
According to IQVIA, US sales for FASLODEX® (fulvestrant injection) for the 12-month period ending March 2019 were USD 541 million (MAT: Moving Annual Total).
Important Safety Information
You should not receive fulvestrant if you have had an allergic reaction to fulvestrant or any of the ingredients in fulvestrant. Talk to your health care provider if you experience symptoms of an allergic reaction to fulvestrant, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.
Before receiving fulvestrant, tell your health care provider about all of your medical conditions, including if you:
Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulant)
Have liver problems
Are pregnant or plan to become pregnant, because fulvestrant can harm your unborn baby. Women who are able to become pregnant should use effective birth control during treatment with fulvestrant and for 1 year after the final dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on fulvestrant
Are breastfeeding or plan to breastfeed. It is not known if fulvestrant passes into breast milk. Do not breastfeed during treatment with fulvestrant and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time
Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Fulvestrant may affect the way other medicines work, and other medicines may affect how fulvestrant works.
Fulvestrant is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of fulvestrant if needed.
Fulvestrant may cause injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a fulvestrant injection: numbness, tingling, or weakness.
Common side effects of fulvestrant include injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.
Approved Uses for Fulvestrant
Fulvestrant is a prescription medicine used to treat women with:
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
HR-positive, HER2‐negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib or abemaciclib, in women whose disease has progressed after endocrine therapy
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine-based therapy or following disease progression on endocrine therapy.
When fulvestrant is used in combination with palbociclib, please also see the palbociclib Patient Information.
When fulvestrant is used in combination with abemaciclib, please also see the abemaciclib Patient Information.
When fulvestrant is used in combination with ribociclib, please also see the ribociclib Patient Information.
It is not known if fulvestrant is safe and effective in children or in people with severe liver problems.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms,
or by express or implied discussions regarding launches, marketing authorizations, new indications or labeling for generic fulvestrant, or regarding potential future revenues from generic fulvestrant. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. There is no guarantee that generic fulvestrant will be successfully launched in the expected time frame, or at all. Nor can there be any guarantee that generic fulvestrant will be commercially successful in the future. In particular, our expectations regarding generic fulvestrant could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional competing versions of generic fulvestrant; our ability to obtain or maintain proprietary intellectual property protection; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from marketing its products; general political, economic and industry conditions; safety, quality or production issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars and a pioneer in the emerging field of prescription digital therapeutics. Our purpose is to pioneer access to healthcare by developing and commercializing novel, affordable approaches that address unmet medical need. Our broad portfolio of high-quality medicines, covering all major therapeutic areas and increasingly focused on value-adding differentiated medicines, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.
*FASLODEX is a registered trademark of AstraZeneca.
1. Robertson JF, Bondarenka IM, Trishkina E, et al. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial. Lancet. 2016;38:2997–3005.