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Review Outlines Glatopa's FDA Approval to Treat MS

Alison Rodriguez
In 2015, the 20 mg/mL dose of the product was approved in the United States as the first generic version of the drug glatiramer acetate and was a fully substitutable generic that was approved for all indications of the dose.
Treatments for multiple sclerosis (MS), such as disease modifying therapies (DMTs), continue to increase in costs. Despite limited evidence that generics and biosimilars could have a major impact on clinical benefit for MS, they provide alternative treatment options and potentially lower costs.

In February 2018, the FDA announced its approval of Glatopa (glatiramer acetate) 40 mg/mL to treat relapsing forms of MS.
Back in 2015, the 20 mg/mL of the product was approved in the United States as the first generic version of the drug glatiramer acetate and was a fully substitutable generic that was approved for all indications of the dose. A recent review considered the scientific processes involved in developing the generic glatiramer acetate that led to the 2015 approval and the recent approval of the 40 mg/mL dose.

"The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products. We look forward to bringing this product to patients and healthcare professionals and providing a full range of patient support services for Glatopa through GlatopaCare®," Richard Francis, CEO, Sandoz said in a statement.

The review explained how generics, approved through the Abbreviated New Drug Application (ANDA) pathway, do not typically require preclinical and clinical data, but must demonstrate physicochemical equivalence and bioequivalence to the innovator drug.

When the FDA approved the first version of glatiramer acetate, Glatopa, it was as a fully substitutable injectable aqueous solution, and because glatiramer acetate is classified as a complex drug mixture of peptides by the FDA, it was eligible for approval through the ANDA pathway.

“The characterization of glatiramer acetate was accomplished through a thorough understanding of the chemistry, manufacturing process, and biological effects of glatiramer acetate, and that involved a detailed characterization of the active ingredient and development of a process that reproducibly yields an equivalent material,” the review stated.

Combined evidence of the efficacy of Glatopa and the reference listed drug, Copaxone, were used to demonstrate equivalence on 4 major criteria, including:
  1. Equivalence of fundamental reaction scheme
  2. Equivalence of physiochemical properties, including composition
  3. Equivalence of structural signatures for polymerization and depolymerization
  4. Equivalence of activity in functional biological assays
Evaluation of these data with the ANDA application led to the approval of Glatopa.

“The experience gained with Glatopa also provides a framework for the development and approval of future generic MS drug products in the United States. Although currently available DMTs reduce the frequency of relapses, manage symptoms, and slow disease progression, the introduction of generic DMTs will lead to future improvements in the affordability and access of these much-needed treatments for MS,” concluded the review.


Bell C, Anderson J, Ganguly T, et al. Development of Glatopa® (glatiramer acetate): The first FDA-approved generic disease-modifying therapy for relapsing forms of multiple sclerosis. J Pharm Pract. 2017:897190017725984. doi: 10.1177/0897190017725984.

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