2017 U.S. sales: $2.23 billion
Disease: Asthma and COPD
Competition expected: Mid- to end-2018
GlaxoSmithKline and its investors have been bracing for competition to top-seller Advair for years. Rightly so, considering the drug lost patent protection back in 2010.
But thanks to the hard-to-copy tech of its Diskus inhaler, many companies have been thwarted in their quest to produce a knockoff, and some—including generics leader Teva—have given up altogether.
There was a time when many assumed Advair would never see a fully substitutable generic rival in the U.S., but that changed back in September 2013, when regulators issued guidance for the development of generic copies of the respiratory superstar. After that, industry watchers changed their tune, asking not “if” copycats would arrive, but “when.”
Despite the guidance, that’s a question that still doesn’t have an answer. Three contenders—Mylan, a Hikma-Vectura team and Novartis’ Sandoz—have already been turned away by U.S. regulators, and it’s unclear how soon one will be able to snag an approval.
Last May, Mylan was the first to face a rejection, despite claims to investors that an approval was all but in the bag. “We have knocked off all of these,” Walt Owens, SVP of global scientific affairs, told investors last March of the FDA’s key approval criteria. “You can check the boxes for all of these components of the draft guidance as being met.”
After receiving its complete response letter, CEO Heather Bresch griped to investors that approval delays would “persist this year as the FDA continues to reorganize and adapt its process and priorities.”
Next in line for a dismissal was the Hikma-Vectura pairing, which didn’t take its “no” lying down. The duo entered a dispute with the FDA which ultimately ended in the agency’s favor; in March, it sent the drugmakers back to the clinic with a request for an additional clinical endpoint study. New ETA? 2020.
All of these regulatory failures set Sandoz up to take the lead—a spot it had earlier tried to petition its way into. But in February, the FDA batted away its application, too, doling out another CRL—and Novartis is now pretty doubtful the product can make its way to market this year.
That means it's up to Mylan to determine just how many years of exclusivity Glaxo has left. While Advair’s U.S. sales have already been whittled away by payer pressure and discounting, GSK will gladly take another year without challengers, especially since it’ll give the company’s new line of respiratory meds—which includes severe asthma drug Nucala and closed-triple therapy Trelegy—some room to grow.
The company is preparing for the worst, though, and that would mean losing half of Advair’s U.S. sales this year. Under that scenario, stateside sales would drop to just £750 million ($1.06 billion), with global sales taking a 25% hit, too.