Mylan NV said that U.S. health regulators were unable to approve its generic version of GlaxoSmithKline’s blockbuster inhaled lung drug Advair for the second time, as they found “minor deficiencies” in the treatment.
Mylan did not provide details on the nature of the deficiencies cited by the U.S. Food And Drug Administration and it remains unclear whether the company will be able to resolve them and get approval this year.
The FDA has declined to approve several Advair knock-offs in the past from drugmakers including Novartis AG, Hikma Pharmaceuticals and Mylan itself, whose generic was rejected last year.
“I don’t think this comes as a big surprise … people realize these are all very difficult-to-make products and they’re going to go through a couple of rounds at the FDA,” Leerink analyst Ami Fadia told Reuters.
The news bodes well for GSK, which has dominated the lung drug market for decades and was bracing for competition by mid-2018.
Even as the British drugmaker puts more marketing muscle on its newer lung drugs, GSK reported revenue of 3,130 million pounds ($4.19 billion) from Advair last year.
(Reporting by Tamara Mathias in Bengaluru; Editing by Maju Samuel)