Viatris launches Breyna, the first outside generic of AstraZeneca’s blockbuster Symbicort

AstraZeneca’s blockbuster asthma and COPD drug Symbicort, which brought in $2.5 billion for the pharma giant in 2022, now has a generics competitor from Viatris.

Viatris teamed up with Kindeva Drug Delivery to launch its own inhalant Breyna, a complex drug-device combo that marks the first outside generic to come to market to compete with Symbicort, Viatris announced Monday. AstraZeneca launched an authorized generic in January 2020.

Breyna was approved by the FDA for asthma in patients 6 years and older and the maintenance treatment of COPD, chronic bronchitis and emphysema, entering a market that has seen few generics over the past three decades. Researchers found that of the 53 inhalers approved by the FDA to treat asthma and COPD from 1986 to 2020, there were generic versions for just four of the brand-name products, thanks in part to the high approval threshold upheld by the FDA and patents on the drug-device combos.

Milton Boyer

“The launch of Breyna represents a significant milestone as it is the first FDA-approved generic version of Symbicort in the U.S., one of the most prescribed complex drug-device combination products to treat asthma and COPD,” Kindeva CEO Milton Boyer said in a statement.

Viatris has set up a copay program to start in August for commercially-insured patients who could pay as little as $20 out-of-pocket for a 30-day supply of the drug. The program also offers $30 per month or up to $360 per year for 12 refills a year.

Symbicort can cost up to $346 for a 30-day supply for patients without insurance, though for those with coverage, the average out-of-pocket cost is about $33. According to AstraZeneca’s 2022 full-year report, Symbicort was the global market leader with its growth driven primarily by Latin America, the Middle East and Asia.

AstraZeneca reported around $1.2 billion in Symbicort sales for the first half of 2023 in its most recent earnings report.

Viatris, formerly known as Mylan, and Kindeva went to bat in court against AstraZeneca in a series of patent challenges that would allow the launch of Breyna. In 2022, a judge ruled in favor of AstraZeneca — but only gave the pharma giant six months of patent protection for Symbicort, which lifted on July 29.

Breyna was approved by the FDA back in March 2022, but couldn’t launch until now because of the ongoing litigation.

AstraZeneca first launched Symbicort in the US in 2007 after FDA approval in 2006 for long-term maintenance treatment of asthma. The drug quickly became a blockbuster, garnering sales of $2 billion in 2008 and steadily increasing to $3+ billion in 2011 and peaking at $3.8 billion in 2014. Sales have since eroded because of generic competition outside of the US.

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