On February 12,2019, Mylan announced the official listing of Wixela Inhub (fluticasone / salmeterol) in the United States. Wixela Inhub is the first generic drug of the GSK star heavy breed Advair Diskus, which was approved twice a day on January 30 for the treatment of tracheal obstruction in asthma patients over 4 years of age and in patients with chronic obstructive pulmonary disease (COPD).
GlaxoSmithKline Advair Global Sales (£ million)
HFA-134A, namely 220.127.116.11-tetrafluoroethane, or aerosol propellant 134a of pharma grade, is now the most commonly used aerosol propellant for MDI such as anti-asthma aerosol, nasal aerosol, foam aerosol and oral aerosol etc. It’s used in all the major high-volume formulations including salbutamol sulphate, beclomethasone diproprionate, ipratropium bromide,fluticasone and their numerous combinations. Some new CBD inhalers are also using HFA-134A as CBD aerosol HFA 134A propellant.
Mylan also announced the wholesale price of three different sizes of Wixela (wholesale acquisition cost, WAC does not represent the actual price paid by consumers, pharmacies or third-party payment agencies), 100μg/50μg, 250μg/50μg, 500μg/50μg The corresponding WAC prices were 93.71, 116.44, and 153.14 dollars, which was 70% lower than the Advair Diskus wholesaler purchase price, and 67% lower than GSK's authorized generics (listed on February 8). At the same time, Mylan will provide patients with training services for Wixela Inhub therapeutic use and device use.
Tony Mauro, chief business officer of Mylan, commented that for the first generic drug launch of Advair Diskus, we have made a huge discount to improve the affordability of the health care system. It is believed that through this, we can save a considerable amount of out-of-pocket expenses for patients, and at the same time save a lot of cost for the US health system.
According to data from the National Heart, Lung, and Blood Institute, asthma affects people of many ages and is more common in children. There are approximately 26 million asthma patients in the United States, of which 7 million are children. COPD is a chronic progressive disease that causes symptoms such as sputum, cough, wheezing, shortness of breath, and chest tightness.
Advair Diskus is a combination of drugs and devices, and the development of such inhaler imitation products is far more difficult than oral solid preparations. The FDA also recognizes the challenges faced by generics companies in developing such complex generic products, including when to load drugs into inhalation devices. In 2013, the FDA released a guide to the development of generic products for Advair, providing some considerations for biosimilars, prescriptions, and device devices for such generics. In addition, the FDA has inspected the production and packaging facilities of generic manufacturers to ensure they are able to produce products that meet strict quality standards.
The FDA will continue to help the industry advance the development of complex generic products by issuing new policies and guidelines. recent. The FDA has issued 27 guidance documents to guide the development of some generic products for transdermal and topical delivery.