The FDA has already struck down two generics of GlaxoSmithKline respiratory blockbuster Advair. But Novartis’ Sandoz is hoping its version can be the one to turn the tide.
Friday, the generics giant announced that U.S. regulators had accepted its regulatory filing for an Advair copy, putting it in position to potentially get a crack at Advair’s multibillion-dollar revenue haul.
"Sandoz scientists and medical experts have developed a high-quality generic option that we believe offers asthma and COPD patients the same safety and efficacy that they expect from Advair,” Sandoz president Peter Goldschmidt said in a statement, adding that “we are confident in our application and data.”
Of course, Sandoz isn’t the first to express confidence in its generic. Walt Owens, SVP of global scientific affairs at Mylan, told investors shortly before the FDA rejected his company’s knockoff, “you can check the boxes for all of these components of the draft guidance as being met.”
"[W]e had several presubmission and postsubmission interactions with the FDA on those three, four, five turns of the information requests. So FDA has been very engaged,” Mylan president Rajiv Malik added at the time.
And since then, another pair of competitors—Jordan’s Hikma and the U.K.’s Vectura—have been stiff-armed by regulators, too. Given “the nature of the feedback” from FDA officials, the companies in May said they saw 2017 approval as a long shot.
The setbacks to its rivals leave Novartis, which was originally trailing behind in its efforts to bring a generic to market, in prime positioning—and it may not be a coincidence, one analyst has posited.
Last October, Novartis urged the FDA in a citizen petition to refrain from approving Advair copies unless they met certain conditions. And in March, Evercore ISI’s Umer Raffat suggested in a research note that the stalling tactic may have worked.
“Had FDA denied the Sandoz citizen's petition outright, it may have implied that FDA does not deem Sandoz's point to be important, and the odds of generic approval” for Mylan “would have been higher. But, that didn't happen,” he wrote.
Meanwhile, the regulatory hurdles have benefitted Glaxo, which may be able to get through 2017 without the added pressure to its top seller. Still, the company has kept its guidance intact: If a generic arrives midyear, it’s expecting core earnings to come in flat or decline by a single-digit percentage, it says.