Ready to take a stab at GlaxoSmithKline’s top-seller Advair, Teva Pharmaceutical Industries on Thursday announced the simultaneous launch of its newly approved AirDuo RespiClick and its authorized generic, which Teva priced at a significant discount to the GSK blockbuster.
With the latter launch, Teva introduced a “true generic” to the market, Evercore ISI's Umer Raffat wrote in a note on what he called a “shrewd” move by the Israeli generics giant. Depending on dose, Teva’s authorized generic, which is not directly substitutable with the Glaxo inhaler, will carry a 69% to 81% discount to the GlaxoSmithKline asthma and COPD stalwart, according to Raffat.
Teva said it expects the authorized generic to reap the most sales out of the two new launches, which contain the same active ingredients as GSK’s Advair. AirDuo RespiClick won FDA approval in February.
Importantly, Teva’s products contain a lower dose of the LABA component than GSK’s Advair and don’t have an FDA approval in chronic obstructive pulmonary disease. Upon an early February approval from the U.S. regulator, Teva said it’d launch the product “later this year,” without providing specifics.
Raffat wrote Thursday that the authorized generic will be a “very important launch” for Teva, an ailing drugmaker that could use a boost after facing a CEO changeup, an expensive settlement with U.S. authorities and criticism over its M&A moves. Last month, the Israeli newspaper Calcalist reported that the company was prepping thousands of layoffs.
The launch comes shortly after the FDA turned away Mylan’s Advair copycat, the latest in a long line of delays for would-be threats to a brand that generated £3.485 billion in global sales last year for London-based GSK. Novartis' generic outfit Sandoz and Jordan's Hikma Pharmaceuticals are also looking to bring a copycat to the market.
All along, GlaxoSmithKline has said Advair genericization would not be routine. While successfully fighting off the patent cliff for several years, the pharma giant has seen sales for the key brand slide. But it introduced Breo and Anoro, new products it hopes can offset the Advair decline.