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FDA Approves Generic Copaxone for Multiple Sclerosis
The FDA has given the green light to the first generic version of Copaxone (glatiramer acetate injection, Teva Neuroscience), used to treat patients with relapsing forms of multiple sclerosis (MS).
Sandoz has received FDA approval to market generic glatiramer acetate (Glatopa) in a 20 mg/1 mL daily injection.
“Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
As needed, the FDA requires appropriate information to demonstrate “sameness” for complex active ingredients, such as glatiramer acetate. For the new approval, FDA scientists established a scientific approach for demonstrating active ingredient “sameness” that takes into consideration the complexity of glatiramer acetate.
MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more often in women than in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, the recovery periods may be incomplete, leading to a progressive decline in function and increased disability. MS patients often experience muscle weakness and difficulty with coordination and balance. Most people experience their first symptoms of MS between 20 and 40 years of age.
In clinical trials of Copaxone, the most common adverse events associated with the drug included injection-site reactions (redness, pain, swelling, and itching), flushing (vasodilation), rash, shortness of breath, and chest pain.
Because glatiramer acetate can modify the body’s immune response, it may interfere with immune functions. For example, treatment with glatiramer acetate may interfere with the recognition of foreign antigens in a way that would undermine the body’s tumor surveillance and its defenses against infection. There is no evidence that glatiramer acetate does this, but there has not been a systematic evaluation of this risk, Sandoz says.
Sources: FDA; April 16, 2015; and Sandoz; April 16, 2015.