Branded glatiramer acetate (Copaxone) was approved by the FDA in 1995 at a dose of 20 mg per day, injected subcutaneously for the treatment of relapsing-remitting MS. It is a “immunomodulatory” medication, and it seems to stimulate protective immunity in MS. It was created to reduce The Costs of treating multiple sclerosis. It is manufactured by Teva Pharmaceuticals and may account for over 50% of that firm’s profits. In 2014, it had sales of almost 4 billion dollars and was in the top 10 of all drugs sold in the US. The patent for this medication expires this year.
The medication is difficult to manufacture. It is a complex and not a simple small-molecule drug. It was first studied in the 1960s, and it took Teva years to produce a commercial product.
The Food and Drug Administration recently approved a generic glatiramer acetate termed Glatopa, manufactured by Sandoz / Novartis. The FDA did not require that a clinical trial be performed to demonstrate equivalence but rather that the generic product met bioequivalence standards consistent with other injectable generic drugs. The agency concluded that the manufacturing method, the physicochemical properties, and the effects on the animal model termed experimental autoimmune encephalitis met these criteria.
By contrast, the European Medicines Agency (EMA) required a clinical trial before considering approval of another generic made by Synthon. This study was recently completed and reported, and the generic seemed as effective as the brand in the primary outcome measure, which was based on MRI findings.
So, Will Generic Copaxone Reduce The Costs Of Treating Multiple Sclerosis? The US product, Glatopa, is priced at $63,000 per year. This is $11,000 a year lower than the brand Copaxone 25 mg a day but is only $2,000 a year lower than the new brand of Copaxone 40 mg 3 times a week, which costs $65,000 per year. Most Copaxone 20 mg a day patients have switched to 40 mg 3 times a week. The generic thus does not replace that product. It takes several years for prices of a generic drug to fall. At some point, we will see generics for beta interferons. Likely, they will not have substantially lower prices than the branded drugs.