As GSK hails its FDA nod for Anoro, a Novartis Advair knockoff prepares for its close-up

GlaxoSmithKline's ($GSK) Advair is not your average off-patent blockbuster. It's difficult to copy, which has held off any major generic competition to date. Now, Novartis' ($NVS) generics unit Sandoz and its partner, Vectura, have won their first approval for a copy of the top-selling lung med--a reminder that the clock is ticking on Advair's turn at the top.

Wednesday, Denmark gave a thumbs up to the generic inhaled drug, dubbed AirFluSal Forspiro, for the treatment of asthma and COPD in patients older than 12. The drug uses a new inhalation device to deliver both mid- and high-strength dosage forms of Advair's active ingredients, salmeterol and fluticasone. Sandoz says the new drug's "safety, efficacy and equivalence have been proven in multiple clinical trials."

According to Sandoz, the two companies have completed authorization procedures in 7 European countries aside from Denmark, and Reuters says other Nordic countries and Germany will likely be among the first to roll out the drug. That could threaten sales of Advair, the $7.7-billion-a-year giant that still has the market cornered three years after losing patent protection.

But there are some considerable silver linings for GSK. While the new product contains both of Advair's active ingredients, it won't be directly substitutable for Advair, Berenberg Bank analyst Alistair Campbell told Reuters. That means it will compete on the market with Advair as other branded rivals might; for AirFluSal Forspiro to draw sales away from Glaxo, doctors will have to specifically prescribe it over Advair. The Sandoz drug will also need the thumbs up from national health authorities in each country before launching, which could be slow going.

And the longer Advair generics take to seriously dig into GSK's sales, the longer the pharma giant has to ready its respiratory franchise's future stars. On that front, Glaxo got a boost Wednesday with an FDA nod for Anoro Ellipta, a COPD treatment with blockbuster potential. Analysts have predicted sales will peak somewhere around $1.4 billion. The Anoro approval follows May's green light for Breo Ellipta, which is projected to surpass $1 billion by 2018.

But even so, those numbers don't add up to Advair's colossal revenue haul, which accounts for nearly a fifth of Glaxo's annual sales. And if the FDA has its way, Advair could be facing rivals in the U.S. sooner than GSK would like. After releasing "relatively basic" draft guidance for generic versions of combination inhaled drugs like Advair, the agency announced plans in November to shorten the review process for those drugs.

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