The U.S. Food and Drug Administration has granted full approval to Viatris for Breyna, the first generic version of AstraZeneca's blockbuster respiratory medication Symbicort. The approval covers maintenance treatment for both asthma and chronic obstructive pulmonary disease (COPD), matching the original drug's indications.
Market Impact and Commercial Landscape
The generic approval comes at a significant time, as Symbicort continues to be a major revenue generator for AstraZeneca, with global sales reaching $2.7 billion in the previous year. The U.S. market accounts for $1.1 billion of these sales, where an authorized generic has been available since early 2020 under license from AstraZeneca.
The newly approved generic, developed through a collaboration between Viatris (formerly Mylan) and Kindeva Drug Delivery, a 3M spin-off company, represents a potential shift in the respiratory medicine landscape. While generic versions of Symbicort are already available in several markets outside the U.S., including Europe, this marks the first full generic approval in the American market.
Patent Challenges and Legal Landscape
The path to market remains complex due to ongoing patent litigation. While Viatris received tentative FDA approval last year, AstraZeneca initially prevailed in a 2021 court case that upheld the validity of three Symbicort patents. However, the landscape shifted in December when a federal court vacated the earlier judgment on appeal, giving Viatris and Kindeva another opportunity to challenge the patent infringement claims.
Viatris has expressed its intention to potentially launch Breyna in 2022 as court proceedings develop, though this could expose them to damage claims if AstraZeneca ultimately prevails in the patent dispute. AstraZeneca maintains its stance, stating they will "continue to vigorously defend and enforce its intellectual property rights."
FDA's Perspective on Generic Approval
Sally Choe, director of the FDA's Office of Generic Drugs, emphasized the significance of this approval, stating, "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."
The approval aligns with the FDA's broader initiative to increase competition and improve access to affordable medicines while maintaining quality and safety standards. This development could potentially lead to reduced treatment costs for patients requiring long-term respiratory medication.
