Two decades of glatiramer acetate: From initial discovery to the current development of generics.

Multiple sclerosis (MS) is a chronic, incurable, inflammatory disease of the central nervous system (CNS). In the United States, several US Food and Drug Administration (FDA)-approved disease-modifying treatments (DMTs) are available, including glatiramer acetate (GA; Copaxone®), one of the most longstanding treatments. GA was discovered serendipitously in the late 1960s/early 1970s while attempting to produce a synthetic antigen capable of inducing experimental autoimmune encephalomyelitis (EAE), an animal model of autoimmune inflammatory CNS disorders, including MS. Instead, GA was found to be protective in EAE models. Subsequent clinical evaluations resulted in GA's FDA approval for relapsing-remitting MS in 1996, followed by a change to the current indication of relapsing forms of MS along with approval of a higher dose and less frequently administered version in 2014. The cost of DMTs including GA remains high, highlighting the potential value of generic therapies for MS. A rigorous scientific approach may be undertaken to demonstrate equivalence between the generic and innovator drug. The introduction of generic versions of GA into the MS treatment landscape has the potential to reduce treatment costs, improving access to these much-needed treatments.