This week, the US Food and Drug Administration approved a generic version of Copaxone. Teva Pharmaceuticals makes the branded version of the multiple sclerosis drug that generates roughly $4.2 billion in annual revenue.
Mylan makes the generic version, and upon the announcement of the approval shares of Mylan jumped up as much as 18 percent while shares of Teva Pharmaceuticals fell by 11 percent.
In a statement, Mylan CEO Heather Bresch said, “Mylan has invested tens of millions of dollars over many years to bring this important medicine to market. Providing patients, healthcare providers and caregivers with treatment options is very important when it comes to selecting the right therapy for relapsing forms of multiple sclerosis.”
Mylan, of course, has earned most of its recent notoriety as the company which dramatically increased the price of its popular—and medically necessary—allergy intervention drug EpiPen. The company justified the price jump as a preparation for the drug losing its patent, which means that other companies could make a generic version.
This time, though, it is Mylan who has made the generic drug and, this time, the drug is intended to treat MS. MS, of course, is a somewhat commonly known central nervous system condition in which the material surrounding your nerve cells—which are responsible for transmitting various signals throughout the body—malfunctions. This disruption can lead to a variety of symptoms including memory problems, muscle weakness, and trouble with coordination.
This is a particularly interesting case, too, in that Copaxone is an injected rug that is a little more complicated to make in a generic form. As a matter of face, FDA Commissioner Scott Gottlieb calls it a “complex generic drug,” an important moniker as the FDA has just named this drug class in an effort to encourage more competition and, most importantly, drive down prices.
Gottlieb notes, “In some cases, costly, branded drugs that are complex drugs have lost their exclusivity, but are subject to no generic competition. The new policies we’re announcing today are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs.”