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Go Glatopa®: generic cost-savings, brand-name quality
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IT’S TIME TO GO GLATOPA:
Generic Savings Backed by Sandoz Quality1
Switch from Copaxone(R) to Glatopa(R)
Glatopa, the first AP-rated, substitutable generic glatiramer acetate (GA), is now available in a 40 mg/mL, 3-times-a-week dosage strength.2-4 Sandoz now offers a complete portfolio to support all patients prescribed GA.
Substantial savings opportunity while maintaining quality of care
Multiple sclerosis (MS) was the fourth most expensive disease area in terms of per member per year specialty drug spend in 2016, and GA is the most widely prescribed MS medication on the market.5,6
32% of all MS prescriptions are for GA(5)
~22% of total GA utilization is represented by the 20 mg/mL dose(6)
~19% of total GA utilization is represented by the 20 mg/mL dose6
~78% of total GA utilization is represented by the 40 mg/mL dose(6)
~81% of total GA utilization is represented by the 40 mg/mL dose6
Source: IMS NPA Monthly as of July 2017.
Glatopa is a cost-effective choice
Generics like Glatopa can offer cost-savings opportunities for the US healthcare system and patients.7 The Institute for Clinical and Economic Review (ICER) found that Glatopa is a cost-effective GA therapy.8
Robust patient support backed by the trusted experience of Sandoz
In addition to therapeutic equivalence and cost-effectiveness, Glatopa offers many of the services you expect with a brand name - including GlatopaCare®, which provides free, individualized patient support. Glatopa is manufactured in the USA, meets rigorous FDA standards, and is backed by the trusted experience of Sandoz, a Novartis Division, known for high-quality generics.3,4,8
To find out more about Glatopa, contact your Sandoz Account Manager or visit glatopa.com.
Indication
Glatopa® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing-forms of multiple sclerosis.

Important Safety Information
Glatopa® is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

Approximately 16% of glatiramer acetate injection 20mg/mL patients vs. 4% of those on placebo, and approximately 2% of glatiramer acetate injection 40mg/mL patients vs. none on placebo experienced a constellation of symptoms that may occur within minutes after injection and included at least 2 of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and urticaria. These symptoms generally have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms. Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.

Transient chest pain was noted in 13% of glatiramer acetate injection 20mg/mL patients vs. 6% of placebo patients, and approximately 2% of glatiramer acetate injection 40mg/mL patients vs. 1% on placebo. While some episodes of chest pain occurred in the context of the immediate post-injection reaction described above, many did not. The temporal relationship of this chest pain to an injection was not always known. The pain was transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment.

At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur. Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. There is no known therapy for lipoatrophy.

Because glatiramer acetate can modify immune response, it may interfere with immune functions. For example, treatment with glatiramer acetate may interfere with recognition of foreign antigens in a way that would undermine the body’s tumor surveillance and its defenses against infection. There is no evidence that glatiramer acetate does this, but there has not been a systematic evaluation of this risk.

The most common adverse reactions with glatiramer acetate injection 20mg/mL vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%). The most common adverse reactions with glatiramer acetate injection 40mg/mL vs placebo were ISRs, such as erythema (22% vs 2%).

ISRs were one of the most common adverse reactions leading to discontinuation of glatiramer acetate injection. ISRs, such as erythema, pain, pruritus, mass, edema, hypersensitivity, fibrosis, and atrophy, occurred at a higher rate with glatiramer acetate than placebo.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for Glatopa.
A, no known or suspected bioequivalence problems; P, injectable solution.
References: 1. Data on File, AnalySource Online. Sandoz Inc. Princeton, NJ. February 2017. 2. Glatopa [prescribing information]. Princeton, NJ: Sandoz Inc.; 2018. 3. FDA approves first generic Copaxone to treat multiple sclerosis [press release]. US Food and Drug Administration; April 16, 2015. https://wayback.archive-it.org/7993/20171102214315/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements /ucm443143.htm. Accessed June 19, 2018. 4. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration website. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf. Accessed June 19, 2018. 5. Express Scripts 2015 Drug Trend Report. Express Scripts website. https://lab.express-scripts.com/lab/drug-trend-report. Published March 2016. Accessed December 4, 2016. 6. Data on File. IMS Health. Sandoz Inc. Princeton, NJ. July 2017. 7. 2016 Generic Drug Savings and Access in the United States Report. Generic Pharmaceuticals Association website. http://www.gphaonline.org/media/generic-drug-savings-2016/index.html. Accessed January 3, 2017. 8. Institute for Clinical and Economic Review. Disease modifying therapies for relapsing-remitting and primary-progressive multiple sclerosis: effectiveness and value. Draft evidence report. November 22, 2016.
Sandoz A Novartis Division
Glatopa and GlatopaCare are registered trademarks of Novartis AG.
©2018 Sandoz Inc., a Novartis Division, 100 College Road West, Princeton, NJ 08540.
All Rights Reserved.
S-GLA-1360830 06/2018
Copyright AJMC 2006-2018 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
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