GSK May Face Sooner-than-Expected Generic Competition
Draft guidance has newly been issued by the US Food and Drug Administration in a stumbling block to GlaxoSmithKline GSK -0.08%.
A report has unveiled that the draft is a hint that generic competition could be faced by the drugmaker for its Advair medication sooner than some people's expectation.
The medication meant for patients of chronic obstructive pulmonary disorder and asthma is second best-selling in the market. More than $7.8 billion was collected by its sales the previous year. But, patent protection is to end in 2016.
It is being said that generics could presently, easily win the approval of FDA on the basis of bioequivalence. Thereby, they jumped into a multi-billion-dollar market merely in a couple of years. And this was the only issue.
Though, there have been implications, it is not certain when a regulatory approval would be won by a completely substitutable generic version in the US. The reason being Advair was a multifaceted blend of a drug and a mechanism called a diskus.
"The vast majority of analysts have assumed that `true' generic versions of Advair would not likely launch in the U. S. This new draft guidance document suggests otherwise", said analyst Tim Anderson from Sanford C. Bernstein & Co.