Developing a generic of GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) asthma inhaler that meets the US Food and Drug Administration’s (FDA’s) requirements is so demanding that few applicants are likely to succeed, Hikma believes. And those that do clear all the hurdles can look forward to a lucrative opportunity with limited competition, the Jordanian group’s chief executive officer, Siggi Olafsson, told investors.
Acknowledging that Hikma could “write a book” about the difficulties in developing a generic of GSK’s blockbuster brand, Olafsson insisted “that also makes it