Novartis, late to the Advair generics party, urges FDA to block rival copycats

Novartis HQ cropped

GlaxoSmithKline isn’t looking forward to generics of its respiratory behemoth, Advair. But third-to-the-party Sandoz isn’t, either--and it’s the one that’s doing its best to trip them up.

The Novartis generics unit has filed a citizen petition on Advair, asking the FDA to refrain from approving generics unless they meet certain conditions, Bernstein analyst Ronny Gal wrote in a Monday note to clients.

The petition advances three arguments for raising the safety bar for Advair copies. Sandoz argues that Advair varies from batch to batch, a factor that “has clinical ramifications”--and it thinks “generics should be held to a higher standard.” Tmax--or the amount of time it takes after a drug is administered for it to reach peak serum concentration--also varies between different Advair doses, with that period shortening in new patients at the low dose, and “per Sandoz, the generics should match that profile.”

The knockoffs giant also thinks the FDA should require Advair copies to meet both those criteria at the same time.

The way Gal sees it, while Sandoz is asking the FDA “to apply a higher standard than that held by the innovator” with the batch variability argument, the FDA “may accept it.” The double standard wouldn’t be unheard of, with biosimilars guidance “explicitly” holding developers to higher manufacturing standards than innovators face, he pointed out.

Sandoz has good reason to attempt to “trip” its competitors. While payer pressure has taken its toll on Advair in recent years, it’s still a multibillion-dollar product--and right now, Mylan is leading the race to steal a piece of the pie. It’s expecting a regulatory decision in March, while Jordan’s Hikma is expecting its own in May--meaning that Sandoz, which hasn’t yet filed its application for approval, is well behind.

And its attempt to stave off generics via citizen petition is nothing new. AstraZeneca recently took up the strategy with Crestor, while Teva went the same route when trying to block copies of multiple sclerosis star Copaxone. Mylan’s own citizen petition may or may not have turned the FDA off of Teva’s rejected EpiPen copy.

Usually, though, it’s a tactic employed by branded drugmakers looking to preserve sales for as long as possible before generics bite in. “This is just another proof of the intense level of competition between generics,” Gal wrote.

Special Reports: The 10 best-selling drugs of 2013 - Advair/Seretide | Top 20 generics companies by 2014 revenue - Mylan

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