Advair Generic May Be Approved in 2018
March 13, 2018 – Although the U.S. FDA recently informed drug manufacturer Hikma that its generic to GlaxoSmithKline’s Advair® Diskus® (fluticasone propionate and salmeterol inhalation powder) would not be approved, experts believe there is still potential for Mylan’s generic to receive the FDA’s nod in 2018.
Advair’s final patent protection (which pertained to its delivery device) expired on August 23, 2016; FDA guidelines for the development of generic alternatives have been in place since 2013. The delay in development and approval of Advair generics arises from the difficulty of effectively replicating the medication/device combination. An inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) contained in a dry powder inhalation (DPI) device, Advair is both chemically and mechanically complex. At this time, there are no combination ICS/LABA inhaled medications available as generics.
Mylan has previously sought and failed to win FDA approval for a generic to Advair. The FDA is expected to reach a decision regarding the company’s resubmitted application in mid-2018, if not sooner. Hikma has responded to its own failure to win approval by committing to further study of its generic; a new application could be submitted as early as 2019, with hopes that the generic would be approved by 2020.
Currently, Teva Pharmaceuticals offers a therapeutic alternative to Advair in its AirDuo™ RespiClick® (fluticasone propionate and salmeterol inhalation powder), which is approved to treat asthma in patients who are least 12 years of age. However, the AirDuo salmeterol dose is less than that found in Advair, meaning that the two drugs are not automatically interchangeable. Teva is expected to submit an application for its own Advair generic soon, and may receive approval as early as 2019.
Indicated for maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD), Advair was first approved by the FDA on August 24, 2000. IQVIA estimates that the product commanded $11.7 billion in sales in 2017.
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