Some Dutch researchers wanted to know how a new generic version of GlaxoSmithKline's ($GSK) asthma drug Advair matches up against the real thing. The issue is whether the Greek generics maker's delivery device--dubbed the Elpenhaler--could match GSK's Diskus, handling-wise. So, they asked GSK to help fund a small trial.
For its part, GSK has maintained the Elpenhaler isn't comparable to its device; therefore, Elpen's Rolenium drug shouldn't be directly substitutable for Advair Diskus. If that's the case, then doctors would have to specifically prescribe the Elpen version, and GSK figures that reduces the threat posed by Rolenium. And as one of GSK's biggest-selling drugs, Advair needs its edge over generic competition.
Will the Dutch trial threaten GSK's argument? The clinical trial's hypothesis is the Diskus device will prove superior to the Elpenhaler, at least measured by ease of use, preference and patient satisfaction, Reuters notes. Plus, the 110-patient study isn't testing the drugs themselves, just the handling characteristics of the respective devices. The inhalers will be tested with placebo drugs rather than Advair or Rolenium. So, there's no risk the generic drug will prove as effective as the branded version--only that patients might somehow prefer the Elpen device.
- read the Reuters story