It is the big sellers, the blockbusters--no, megablockbusters--that drug execs aspire to develop. And a look at the top 10 best-selling drugs globally can't help but impress with its big numbers.
GlaxoSmithKline's asthma behemoth Advair may be losing ground in Europe, but a legal win may stop some of the bleeding--at least in Germany. The British pharma giant has obtained a preliminary injunction there to stop Novartis' Sandoz from hawking its generic, AirFluSal Forspiro, thanks to the inhaler's purple color.
With aging top dog Advair losing ground to generic and branded competitors alike, GlaxoSmithKline is grooming a lineup of respiratory up-and-comers to step in with their own blockbuster sales. And new study results comparing Advair with not-yet-launched Anoro Ellipta could help the fledgling COPD treatment do just that.
While it's still unclear how long copycats will take to make a serious dent in GlaxoSmithKline's respiratory franchise once generic competition inevitably erodes sales of the $8.8 billion-selling Advair, Glaxo may soon have a new building block with European regulators' new recommendation for combo med Anoro.
Advair's throne is slowly eroding. With stepped-up competition from rival lung drugs--including AstraZeneca's Symbicort--GlaxoSmithKline's top-selling product, with $7.7 billion in 2012 sales, is losing share in the U.S.
After Denmark approved AirFluSal Forspiro in December, the respiratory generic scored an approval in Germany and now has its third thumbs-up from Sweden.
GlaxoSmithKline's ($GSK) respiratory franchise got a boost from the FDA Wednesday, and not a moment too soon. The agency green-lighted its COPD treatment Anoro Ellipta just as a generic of Glaxo's top-selling Advair won its first approval--a reminder that competition for the lung giant may be just around the corner.
GlaxoSmithKline's Advair is not your average off-patent blockbuster. It's difficult to copy, which has held off any major generic competition to date. Now, Novartis' generics unit Sandoz and its partner, Vectura, have won their first approval for a copy of the top-selling lung med--a reminder that the clock is ticking on Advair's turn at the top.
GlaxoSmithKline's Advair is hard to copy. Some companies have given up on generic Advair, while others have shied away altogether despite the substantial sales up for grabs. But what if generics makers had some help--and an expedited review process--from the FDA?
The key is Advair's Diskus inhaler device. While patents on Advair's active ingredients have expired, the one on Diskus will protect the drug until 2016--and beyond, if generics makers face challenges in bringing quality copies to market.