FDA Greenlights Two Generic Glatiramer Acetate Formulations for Relapsing MS

Wednesday, October 04, 2017

The FDA approved Mylan’s generic versions of glatiramer acetate, including a three-times weekly 40mg/mL formulation of glatiramer acetate and a once-daily 20mg/mL formulation. As part of its Abbreviated New Drug Applications, Mylan submitted side-by-side analyses, including characterization data, demonstrating that its formulations have the same active ingredient, dosage form, route of administration, and strength as their branded counterpart Copaxone (Teva). Because Mylan was one of the first applicants to submit a substantially complete Abbreviated New Drug Application for the 40mg/mL formulation, it may be eligible for 180 days of generic drug exclusivity, however the FDA has not made a formal determination on exclusivity at this time.

In addition, Mylan has introduced a new patient support program, Mylan MS Advocate, to help patients get started on and stay on track with their physician's treatment plan for either dose strength of Mylan's glatiramer acetate injection. The program includes an interactive mobile app, in-home injection training, a 24/7 patient support center, co-pay assistance for eligible patients, and ongoing support from an MS-experienced nurse.

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