AstraZeneca’s widely successful drug, Symbicort, known for its effectiveness in treating asthma and COPD, brought in an impressive $2.5 billion for the pharmaceutical giant in 2022. However, the market dynamics are changing as Viatris enters the scene with Breyna, a new generic competitor. Teaming up with Kindeva Drug Delivery, Viatris introduced Breyna, a complex drug-device combination, making it the first generic outside competitor to challenge Symbicort’s dominance. This development was announced on Monday, marking a significant shift in the industry. Notably, AstraZeneca had previously launched an authorized generic version of Symbicort in January 2020.
Breyna received the green light from the FDA for asthma treatment in patients aged 6 years and older, as well as for the maintenance of COPD, chronic bronchitis, and emphysema. The entrance of Breyna into the market is particularly noteworthy because generic alternatives for asthma and COPD inhalers have been scarce over the past three decades. Out of the 53 inhalers approved by the FDA from 1986 to 2020, only four had generic versions, largely due to the strict approval thresholds and patents governing drug-device combinations.
Kindeva CEO, Milton Boyer, expressed excitement about the launch of Breyna, emphasizing that it is the first FDA-approved generic version of Symbicort in the United States. As part of their commitment to providing accessible healthcare, Viatris introduced a copay program, set to start in August. This program aims to support commercially-insured patients, offering them the opportunity to obtain Breyna with a minimal out-of-pocket cost of $20 for a 30-day supply. Additionally, the copay program extends to a $30 per month benefit or up to $360 per year for 12 refills.
Symbicort’s pricing can be considerably higher, reaching up to $346 for a 30-day supply for patients without insurance. However, those with insurance typically face an average out-of-pocket cost of around $33. Despite its global market leadership, Symbicort’s growth has faced challenges due to generic competition outside the United States.
The road to Breyna’s launch was not without hurdles. Viatris, previously known as Mylan, and Kindeva engaged in legal battles against AstraZeneca, seeking the necessary patent challenges to introduce Breyna to the market. In 2022, a judge ruled in favor of AstraZeneca, granting the pharma giant only six months of patent protection for Symbicort, which expired on July 29. The FDA had already granted approval for Breyna in March 2022, but its launch was delayed due to the ongoing litigation.
AstraZeneca originally launched Symbicort in the US in 2007 following FDA approval in 2006 for the long-term maintenance treatment of asthma. The drug rapidly gained popularity, achieving sales of $2 billion in 2008 and steadily increasing to over $3 billion in 2011, with a peak of $3.8 billion in 2014. However, the introduction of generic alternatives outside of the United States led to a decline in Symbicort’s sales over time.
In conclusion, Viatris and Kindeva’s successful challenge to launch Breyna, the first FDA-approved generic version of Symbicort, marks a significant development in the asthma and COPD treatment landscape. The copay program for Breyna aims to make the medication more accessible and affordable for patients, setting a new course in the pharmaceutical industry.
First Generic Competitor
