For Healthcare Professionals

Favorable commercial coverage and healthcare cost savings

Glatopa provides patients with the accessibility and affordability that only a generic can provide.

Glatopa % of coverage

Glatopa of coverage

Nearly all commercial plans cover Glatopa, and most plans have preferred formulary status for Glatopa vs Copaxone® (glatiramer acetate injection)2

Generic medications like Glatopa offer cost-saving opportunities for the US healthcare system3

  • Generics saved $235B in the US in 20163
  • In 2016, the US healthcare system spent $18.7B on MS treatment4*
  • In 2016, One-third of all prescriptions for the treatment of relapsing forms of MS are for glatiramer acetate
  • Glatopa, a generic glatiramer acetate, offers an opportunity for substantial savings in MS and potentially lower costs for eligible patients without compromising quality of care
  • Glatopa 20 mg/mL already accounts for approximately 40% of total glatiramer acetate 20 mg/mL prescriptions since its launch in June 2015, potentially saving money for thousands of patients5,6

*Classified by invoice spending.

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 20 mg/mL patients vs 4% of those on placebo, and approximately 2% of glatiramer acetate injection 40 mg/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 paint was noted in 13% of glatiramer acetate injection 20 mg/mL patients vs 6% of placebo patients and approximately 2% of glatiramer acetate injection 40 mg/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 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 time 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 20 mg/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 40 mg/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.

References

  1. Glatopa [prescribing information]. Princeton, NJ. Sandoz, Inc., 2017.
  2. Data on File. Fingertip Formulary. Sandoz Inc. Princeton, NJ. November 2016.
  3. 2017 Generic Drug Savings & Access in the United States Report. Generic Pharmaceutical Association website. https://accessiblemeds.org/sites/default/files/2017-07/2017-AAM-Access-Savings-Report-2017-web2.pdf. Accessed March 23, 2018.
  4. Medicines Use and Spending in the U.S.—A Review of 2016 and Outlook to 2021. IQVIA Website. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/medicines-use-and-spending-in-the-us.pdf. Accessed March 23, 2018.
  5. Data on File. IMS Health. Sandoz Inc. Princeton, NJ. 2017.
  6. Data on File. Glatopa sales data. Sandoz, Inc. Princeton, NJ. 2017.