Novartis’ prospects for launching a copy of GlaxoSmithKline’s Advair this year just went from highly unlikely to not happening.
That would-be generic was turned back by the FDA in February, and now the company expects to have to complete a small bioequivalence bridging study, CEO Vas Narasimhan told investors Thursday on Novartis' first-quarter conference call.
“Our plan will be to get that study started,” Narasimhan said. Updated launch timeline? “Before the end of 2019.”
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While Narasimhan insisted that Novartis doesn’t view the study “to be a significant hurdle for what we can see right now,” it’ll hold up the product well beyond its initial FDA decision date. That much was already clear in February when the FDA issued a complete response letter asking for more data, but just how far beyond was the question.
Setbacks from Jordan-based Hikma—which as of March still needs to come up with an additional endpoint study—and Novartis' Sandoz unit could put Mylan back in the lead spot, despite being the first company to net an FDA rejection for its Advair knockoff.
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Meanwhile, Advair-maker GlaxoSmithKline continues to enjoy its time in the sun. After last year setting out financial forecasts revolving a generic Advair hit that never came, this year it said knockoffs could eat up half its U.S. sales—or £750 million—if they launch midyear. Now, though, it just has to dodge a Mylan bullet in order to escape that possibility.