Regulatory

GSK wins yet another reprieve for blockbuster Advair franchise as Mylan is hit (again) with a CRL

GlaxoSmithKline CEO Emma Walmsley is working on rebuilding the pharma giant’s R&D operation with some of the best minds in the business. But in the meantime, she can rely on repeated setbacks among her rivals to win some badly needed breathing room.

Emma Walmsley

Case in point: Wednesday evening Mylan reported that the FDA had kicked back its copycat version of Advair, again. This follows a whole slate of rejections for companies looking to grab the mega-blockbuster franchise away with cheaper copies of the respiratory drug.

The complete response letter won’t be delivered until June 27, says Mylan, which is trying to downplay the rejection by saying regulators had identified only “minor deficiencies” in the application. In addition, Mylan also said that their priority review designation from the FDA could tee up an approval sooner rather than later.

There was no explanation, though, of what Mylan has to do to correct those deficiencies.

Mylan shares $MYL dropped close to 5% on the news.

How important is this for GlaxoSmithKline?

GSK has $3 billion in annual sales from Advair, and said earlier when Novartis was hit with a CRL for its Advair knockoff that the absence of a generic competitor through 2018 could add 7% to this year’s earnings. 

A few weeks ago the FDA sent Hikma back to the clinic to do a new study on its Advair knockoff, delaying that product by at least a couple of years.

Mylan plans to wait until after the letter arrives to determine what impact the CRL will have on its annual numbers. And GSK can celebrate yet another dodged bullet.


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