Those waiting for Hikma and Vectura’s copy of GlaxoSmithKline blockbuster Advair may be waiting awhile.
After receiving a May rejection of the knockoff from the FDA, Hikma now says the partners are locked in a dispute with the agency that won’t be resolved until next year’s first quarter. Once that’s settled, “we will update the market and provide further details on timelines,” the company said in a statement.
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At the root of the tussle is “an outstanding issue” regarding the team’s clinical endpoint study, according to Hikma, which says it “firmly” disagrees with the FDA’s position. The rest of the questions regulators raised around the turned-down application have been clarified and addressed, the drugmaker added.
Hikma’s lengthy delay could make Novartis’ Sandoz a come-from-behind winner in the race to bring a cheap copy of GSK’s respiratory blockbuster to market. Before Hikma, Mylan saw its own application turned aside by the FDA, and it’s since removed the product from its 2017 guidance.
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That leaves Sandoz—which was once lagging far enough behind that it filed a citizen petition urging the FDA toward stricter approval standards—potentially first in line for a green light. And at least one analyst thinks the company might have the petition to thank.
Meanwhile, Glaxo will take all the copycat-free time it can get with Advair, whose respiratory sales have dwindled under payer pressure even in the absence of generic competition. On its earnings call late last month, the British drugmaker outlined “ongoing pressures” in the business for next year, which doesn’t seem to present “a lot to look forward to,” Bernstein analyst Tim Anderson wrote to clients at the time.