FDA strikes down Mylan's generic Advair—again—citing 'minor' issues

Thought Mylan might snag a generic Advair approval on its second try? Think again.

On Wednesday, the company said an FDA rejection for its copy of the GlaxoSmithKline respiratory behemoth was on the way, thanks to “minor deficiencies” in its application. The agency will dig into what those are in a Complete Response Letter, which it’ll issue on June 27.

While the outcome isn’t what Mylan wanted, the company said the damage may not be that bad. Its application has a priority designation, meaning that once the drugmaker responds to the CRL, it could win approval within 90 days. It’ll wait until after it officially receives the CRL to determine how big a hit—if any—its 2018 earnings will take on the delay, it said.

The way Leerink Partners analyst Ami Fadia sees it, “the issues may be resolved to get approval by year end.” Wells Fargo analyst David Maris, for his part, added that “minor deficiencies are often very easily addressed.”

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But as industry watchers have seen with a slew of generic Advair failures, “in the end, the bar for approval of generic respiratory inhalers remains a moving target and crossing the goal line remains difficult to reach,” Fadia wrote to clients.

Mylan was the first to get the FDA’s cold shoulder for an Advair copy last March, but partners Hikma and Vectura followed up with their own dismissal in May. That left Novartis’ Sandoz, once third in line, a chance to line up a come-from-behind victory—until the FDA earlier this year asked the generics giant for more data.

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Even with the latest rejection, Mylan still has an opportunity to come in first, considering that U.S. regulators in March sent Hikma and Vectura back to the clinic with a request for another clinical endpoint study. And on the earnings front, whether the company launches in 2018 or early 2019 “makes little difference,” Bernstein analyst Ronny Gal wrote in a note to his own clients.

Maris agreed that the news was negative for Mylan, “but less so from a financial basis than a sentiment basis.”

“We believe this delay is important as this is a high profile product that may already be in market expectations, and the delay may take away some excitement about a near-term catalyst,” he wrote.

Meanwhile, the more delays on Advair copies, the better for GlaxoSmithKline. The British drugmaker has said that a generic entry in the middle of 2018 could strip half the drug's U.S. sales.