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Glatopa® (glatiramer acetate injection)

Glatopa® (glatiramer acetate injection) is a once daily and fully substitutable generic equivalent of daily COPAXONE® 20 mg/mL. Glatopa is the first AP-rated substitutable generic indicated for the treatment of patients with relapsing-forms of multiple sclerosis (MS), a devastating chronic disease of the central nervous system characterized by inflammation and neurodegeneration.  COPAXONE is among the leading products marketed for treatment of relapsing-forms of MS. It works by stopping the body from damaging its own nerve cells (myelin).

Glatopa was developed by way of a collaboration between Momenta and Sandoz and is commercialized under the Sandoz brand. Characterizing COPAXONE represents another significant technical challenge for generic manufacturers given its complex mixture of polypeptide chains of various lengths and sequences. Momenta addressed this challenge with our core characterization and process engineering capabilities to successfully develop and manufacture Glatopa, which was launched in June 2015. The ANDA for a three times weekly generic COPAXONE 40 mg/mL (glatiramer acetate injection) has been accepted for review by the FDA.

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COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd. Glatopa® is a registered trademark of Novartis AG.

Last Updated 8/31/2016