For Healthcare Professionals

Glatopa is the first FDA-approved generic formulation of glatiramer acetate1-5

Glatopa has met the rigorous FDA standards outlined by the FDA for the approval of generics.

4-point criteria for approval

4-point criteria for approval


Glatopa is made in the USA

Glatopa is manufactured using processes that meet FDA quality standards1-4,6

Glatopa is made in the USA by Sandoz, a Novartis Division.

Leading the way in glatiramer acetate generics1,2

As the first generic glatiramer acetate to market, Glatopa 20 mg/mL has over 3 years of real-world experience with patient-focused results.

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. FDA approves first generic Copaxone to treat multiple sclerosis [press release]. US Food and Drug Administration; April 16, 2015.
  2. 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 March 14, 2018.
  3. Abbreviated New Drug Application (ANDA): Generics. US Food and Drug Administration. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/. Updated November 16, 2016. Accessed November 21, 2016.
  4. Glatopa [prescribing information]. Princeton, NJ: Sandoz Inc.; 2018.
  5. Anderson J, Bell C, Bishop J, et al. Demonstration of equivalence of a generic glatiramer acetate (Glatopa). J Neurol Sci. 2015;359(1-2):24-34.
  6. Glatopa (glatiramer acetate injection) approved for the long-term treatment of relapsing forms of MS [press release]. Multiple Sclerosis Association of America; April 17, 2015.