Princeton, December 7, 2016 – Sandoz today announced the US market introduction of bimatoprost ophthalmic solution, 0.03% (0.3 mg/mL), which is a generic version of Allergan’s Latisse.
Bimatoprost ophthalmic solution, 0.03%, is a prescription medicine indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness and darkness.
"The launch of bimatoprost is an important addition to our industry-leading portfolio of ophthalmic products,” said Peter Goldschmidt, President of Sandoz Inc. “By expanding our ophthalmic offerings, Sandoz will increase patients’ access to a comprehensive range of quality medicines at affordable prices.”
According to IMS Health, US sales for Latisse were approximately USD 75 million for the twelve-month period ending in October. Sandoz is marketing bimatoprost in the same 0.03% strength as the branded product.
Important Safety Information
If you use/used prescription products for eye pressure problems, use bimatoprost under doctor care. Bimatoprost may cause increased brown pigmentation of the colored part of the eye, which is likely permanent. Eyelid skin darkening may occur and may be reversible. Only apply at the base of upper lashes. DO NOT APPLY to lower lid. Hair may grow on skin that bimatoprost frequently touches. If you have eye problems/surgery, consult your doctor about use of bimatoprost. Common side effects are itchy and red eyes. If discontinued, lashes gradually return to previous appearance.
Warnings and Precautions:
Effects on Intra-Ocular Pressure (IOP): In patients using Lumigan® or other prostaglandin analogs for the treatment of elevated IOP, the concomitant use of bimatoprost ophthalmic solution, 0.03% may interfere with the desired reduction in IOP. Patients using prostaglandin analogs, including Lumigan®, for IOP reduction should only use bimatoprost ophthalmic solution, 0.03% after consulting with their physician and should be monitored for changes to their IOP.
Increased iris pigmentation has occurred when bimatoprost solution was administered.
Patients should be advised about the potential for increased brown iris pigmentation, which is likely to be permanent.
Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients.
There is the potential for hair growth to occur in areas where bimatoprost solution comes in repeated contact with skin surfaces. Apply bimatoprost ophthalmic solution only to the skin of the upper eyelid margin, at the base of the eyelashes.
Bimatoprost ophthalmic solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Bimatoprost contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.
Adverse Reactions The most frequently-reported adverse events were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and erythema of the eyelid. These events occurred in less than 4% of patients.
Postmarketing Experience: The following reactions have been identified during postmarketing use of bimatoprost ophthalmic solution in clinical practice: eye swelling, eyelid edema, hypersensitivity (local allergic reactions), increased lacrimation, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and blurred vision.
You are encouraged to report negative side effects of prescription drugs to FDA. Visitwww.fda.gov/medwatch, or call 1-800-FDA-1088.
The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” “launch,” “will,” or similar terms, or by express or implied discussions regarding potential future product approvals or launches, or regarding potential revenues from generic bimatoprost or other products in the Sandoz ophthalmic portfolio. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management 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. There can be no guarantee that any potential new products will receive regulatory approval in the future, or that generic bimatoprost or any other products in the Sandoz ophthalmic portfolio will be commercially successful in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general, including potential approval of additional versions of generic bimatoprost; government, industry and general public pricing pressures; unexpected patent litigation outcomes; unexpected safety, quality or manufacturing issues; general economic and industry conditions, 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.
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our global portfolio comprises approximately 1000 molecules, covering all major therapeutic areas, which accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached well over 500 million patients worldwide and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.
For general inquiries, to report a side effect (adverse event), product complaint or customer inquiry, please call 1-800-525-8747