Good news, Glaxo: Novartis' Advair copy definitely won't see the market this year

FDA
The FDA wants a bioequivalence study from Novartis before it approves its Advair copy. (FDA)

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.”

Featured Whitepaper

Accelerate Clinical Operations Across Sponsors, CROs, and Partners

The most advanced life sciences organizations know that digital innovation and multi-platform integrations are essential for enabling product development. New platforms are providing the life sciences industry with an opportunity to improve the efficiency of clinical trials and reduce costs while remaining compliant and reducing risk.

RELATED: Bad news for Novartis, good for GlaxoSmithKline: Sandoz' Advair copy stiff-armed at FDA

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.

RELATED: GlaxoSmithKline's upward trajectory faces a £750M knock with Advair copies. What can fill the gap?

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.

Suggested Articles

AstraZeneca and Brazil have expanded their deal for a possible COVID-19 vaccine, this time to the tune of $360 million.

Novavax expects to churn out enough vaccines in 2021 to meet U.S. demand; experts slam the medical and political risks of Russia's unproven vaccine.

Novavax will have billions of doses of COVID-19 vaccine capacity next year and could single-handedly meet U.S. demand, executives said.