Sweden approves copy of GSK asthma blockbuster

It looks as if GlaxoSmithKline's ($GSK) Advair could finally get some real competition. Swedish regulators have approved a knock-off version of the asthma drug, which brought in more than $8 billion in 2010 sales for GSK, paving the way for it to be sold in Germany, Italy, Portugal, Hungary and the Czech and Slovak Republics, Reuters reports.

The new version, made by Greece's Elpen, has been on sale in that company's home market since 2009 under the brand name Rolenium. It hasn't captured much market share there--just 9 percent, Reuters finds, while GSK holds onto 43 percent of that business.

And GSK is downplaying the idea that it will make big inroads anywhere else. That's because the delivery device is quite different from Advair's. Elpen's version requires patients to load a blister strip containing the two active ingredients. GSK's Seretide Accuhaler/Diskus--sold as Advair Diskus in some markets--is a dry powder inhaler, a spokesman noted. "[I]t is substantially different from the Elpen device," a company spokesman told Reuters. "GSK therefore believes the products would not be substitutable."

And "substitutable" is a keyword. If generic knock-offs aren't deemed freely exchangable with the branded versions, they have to be prescribed by name. That could definitely hinder Elpen's ability to compete with the Advair brand.

GSK CEO Andrew Witty (photo) has been promising that this sort of problem--along with the technical challenges of coming up with a workable delivery device--offers a measure of protection for his branded drug. Other versions from bigger generics makers are waiting in the wings, however, so that protection may not last long.

- get the Reuters news