FDA approves the first generic of Symbicort

Yesterday, the US Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The FDA granted approval of this generic budesonide and formoterol fumarate dihydrate inhalation aerosol to Mylan Pharmaceuticals, one of the partners in the recently created biosimilars power house Viatris (Nasdaq: VTRS). The branded Symbicort was developed and is marketed by UK-based AstraZeneca (LSE: AZN). The drug generated global sales of $2.73 in 2021, $1,065 million of which were generated in the USA.

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, director of the Office of Generic Drugs in the FDA Center for Drug Evaluation and Research, adding: “This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”