Mylan Inc. issued the following announcement on April 21.
Mylan Presents Equivalence Data on Glatiramer Acetate Compared to Copaxone® at American Academy of Neurology 70th Annual Meeting.
Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced three scientific abstracts from the Glatiramer Acetate development program will be presented at the American Academy of Neurology (AAN) 70th Annual Meeting in Los Angeles, April 21-27.
The data, available for the first time publicly, further supports the U.S. Food and Drug Administration's approval in October 2017 of Mylan's Abbreviated New Drug Applications for Glatiramer Acetate Injection 40 mg/mL and 20 mg/mL formulations.
Mylan's Head of Morgantown Research & Development Patrick Vallano commented, "We are excited to present at this year's American Academy of Neurology annual meeting Mylan's rigorous equivalence data that demonstrated sameness between Mylan's Glatiramer Acetate and Copaxone®.
The three posters describe the testing and characterization analyses conducted to show comparability in fundamental chemistry, physiochemical properties and molecular pathways between the two products. We believe a world-renowned venue like AAN's annual meeting is the perfect opportunity for Mylan to showcase and discuss the strong science behind our Glatiramer Acetate."
Mylan's data will be presented during the following poster sessions at the meeting and later available in "Neurology," the official journal of AAN.
Abstract 3323: Demonstration of Equivalence of Generic Glatiramer Acetate (GA) Produced by Mylan to Copaxone®
April 22, 4 p.m. to 5:30 p.m. PST
Poster Session P1
Poster #361
Abstract 3177: Characterization and Comparison of the Gene Expression Profiles of Copaxone® and Mylan Glatiramer Acetate
April 22, 4 p.m. to 5:30 p.m. PST
Poster Session P1
Poster #376
Abstract 3183: Generation and Analysis of Human T Cell Lines Responsive to Glatiramer Acetate
April 26, 5:30 p.m. to 7 p.m. PST
Poster Session P5
Poster #363
Full session details and abstracts for the 2018 Scientific Sessions can be found at the American Academy of Neurology's website at www.aan.com.
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