Generic Version of Advair Diskus Launched at Discounted List Price
The FDA announced approval of Wixela Inhub on January 30, 2019.
This article was originally published on Pharmacy Times.
The first FDA-approved generic version of Advair Diskus (GlaxoSmithKline [GSK]), a fluticasone propionate and salmeterol inhalation powder product, has been launched, Mylan N.V. announced today.1
Mylan’s product (Wixela Inhub) will be offered in 3 strengths at wholesale acquisition costs (WACs). The WACs for 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths are $93.71, $116.44 and $153.14, respectively.1
According to Mylan, its WACs for Wixela Inhub are 70% less than that of Advair Diskus and 67% less than GSK’s authorized generic equivalent, which was launched February 8, 2019.1
However, officials with Mylan have said its WACs may not reflect the prices paid by consumers, pharmacies or third-party payers.1
"We've had numerous discussions with customers about the need for a unique launch strategy for the first substitutable generic of Advair Diskus that increases affordability to all in our health care system. We trust that by launching Wixela Inhub at a significantly discounted list price, we will demonstrate the savings that generics can deliver for patients through reduced out-of-pocket costs, as well as the U.S. healthcare system overall,” said Mylan's Chief Commercial Officer Tony Mauro, in a prepared statement.1
Mylan also plans to offer patient services to provide training and education about this treatment and inhalation device.1
In the United States, 26 million people, including children, have asthma and 16 million people are living with COPD. According to the FDA, Wixela Inhub should provide greater patient access to this medication.2
This generic product is indicated for the twice daily treatment of asthma in patients age 4 years and older not adequately controlled on long-term asthma medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta agonists; maintenance treatment of COPD; and the reduction of COPD exacerbations in patients with a history of exacerbations. It is not indicated for the relief of acute bronchospasm.2
The FDA announced approval of Wixela Inhub on January 30, 2019. This product was approved through the agency’s Abbreviated New Drug Application (ANDA) pathway.2
- Mylan Launches Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP), the First Generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder), at a List Price 70% Less than the Brand [news release]. Hertfordshire, England and Pittsburgh, Pennsylvania; February 12, 2019: Mylan website. http://investor.mylan.com/news-releases/news-release-details/mylan-launches-wixelatm-inhubtm-fluticasone-propionate-and. Accessed February 12, 2018
- FDA approves first generic Advair Diskus [news release]. Silver Spring, MD; January 30, 2019: FDA website. http://www.pharmacytimes.com/link/251. Accessed January 30, 2019.