By Ben Hirschler
LONDON (Reuters) – Israel’s Teva Pharmaceutical Industries has gained U.S. approval to market a replica of GlaxoSmithKline’s best-selling Advair inhaler, though the actual battle continues to be to come.
Teva’s model of GSK’s blockbuster drugs, referred to as AirDuo RespiClick, isn’t immediately substitutable for Advair and is just accredited for bronchial asthma, whereas Advair can also be extensively used for persistent obstructive pulmonary illness (COPD).
Teva stated on Monday it might launch AirDuo later this yr. It has not stated how a lot its product will value.
AirDuo offers sufferers with the identical two medicine as Advair, fluticasone propionate and salmeterol, however it delivers a decrease dose of salmeterol. It additionally makes use of Teva’s Respiclick inhaler relatively than a replica of GSK’s gadget.
Producing cut-price copies of Advair is a serious alternative for generics corporations at a time when fewer blockbuster medicines are dropping patent safety.
For GSK, it’s a problem since Advair has bought greater than $1 billion yearly since 2001. Global Advair gross sales have been $5.6 billion in 2015, with half that generated within the United States, though gross sales at the moment are shrinking.
Teva’s product guarantees to seize a few of this enterprise in bronchial asthma however the greater menace will come from absolutely substitutable generic copies of Advair, that are nonetheless pending approval.
The U.S. Food and Drug Administration is due to determine whether or not to approve the primary of those, from Mylan, by March 28. A rival model from Hikma and Vectura is shut behind, with an approval date of May 10.
GSK stated that as Teva’s product was not substitutable for or equal to Advair it didn’t “pose the same competitive dynamics as market entry of generic products in the U.S. would.”
Advair is already obtainable generically in Europe, however demand for copies is predicted to take off extra swiftly within the United States, the place managers of prescription plans can shortly drive conversion to such cheaper merchandise.
Investors are watching intently to see how GSK’s Advair gross sales will fare within the face of latest rivals. One huge unknown is the size of reductions that shall be provided by generic corporations.
(Reporting by Ben Hirschler; Editing by Susan Fenton)