The U.S. Food and Drug Administration today approved the first
generic version of Copaxone (glatiramer acetate injection), used to
treat patients with relapsing forms of multiple sclerosis (MS). Sandoz has received FDA approval to market generic glatiramer acetate in a 20 mg/1 ml daily injection. “Health care professionals and patients can be assured that
FDA-approved generic drugs have met the same rigorous standards of
quality as the brand-name drug,” said Janet Woodcock, M.D., director of
the FDA’s Center for Drug Evaluation and Research. “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.”
The FDA applies the same rigorous and reliable standards to evaluate
all generic drug products. As needed, the agency requires appropriate
information to demonstrate sameness for complex active ingredients, such
as glatiramer acetate. For this approval, FDA scientists established a thorough 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 frequently in women than men.
For most people with MS, episodes of worsening function (relapses) are
initially followed by recovery periods (remissions). Over time, recovery
periods may be incomplete, leading to 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 the ages of 20 and 40.
In the clinical trials for Copaxone, the most common adverse
reactions reported by those taking Copaxone were skin problems at the
injection site (redness, pain, swelling and itching), flushing
(vasodilation), rash, shortness of breath and chest pain.
The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation’s food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.