16 Sep Multiple Sclerosis: Generic Copaxone Demonstrates Equivalent Safety and Efficacy
MedicalResearch.com: Interview with:
Jeffrey A. Cohen, MD
Hazel Prior Hostetler Endowed Chair
Professor, Cleveland Clinic Lerner College of Medicine
Director, Mellen Center for MS Treatment and Research
Cleveland Clinic Cleveland, OH 44195
Medical Research: What are the main findings of the study?
Dr. Cohen: The primary objective of the GATE trial was to compare the efficacy and safety of generic glatiramer acetate to the approved form (Copaxone) in relapsing-remitting multiple sclerosis. The study demonstrated equivalent efficacy of generic glatiramer acetate and Copaxone measured by gadolinium enhancing brain MRI lesions at months 7, 8, and 9 and a number of additional measures of MRI lesion activity. The study also showed comparable safety (measured by adverse events) and injection site tolerability.
Medical Research: What should clinicians and patients take away from your report?
Dr. Cohen: Medications contribute significantly to the high cost of multiple sclerosis care. As the patents expire for MS disease medications, there is the opportunity to develop generic versions with potential cost savings for patients and payors. However, since MS disease medications are biologics, large molecules, or complex molecular mixtures, adequate testing probably will include not only extensive chemical, physicochemical, toxicological, and immunological testing but also clinical trials.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Cohen: Ongoing studies of generic glatiramer acetate include an open label extension study to provide additional efficacy and safety data on generic glatiramer acetate up to two years and data on switching from Copaxone to generic glatiramer acetate. Immunogenicity studies also are in progress.