The FDA has approved a generic version of AstraZeneca’s Symbicort budesonide / formoterol fumarate MDI from Mylan (now Viatris), the agency announced. The FDA tentatively approved the Mylan ANDA in March 2021 just after a court had ruled in favor of AstraZeneca in its suit against Mylan and Kindeva Drug Delivery (formerly 3M Drug Delivery). In December 2021, an appeals court reversed the March 2021 decision and returned the case to the lower court.
According to Viatris and Kindeva, the inhaler will be marketed as “Breyna,” with a potential for a 2022 launch depending on the course of the patent litigation. At the time of the tentative approval, Kindeva said that it planned to manufacture the MDI at its California facilities following final approval of the ANDA.
In its announcement, the FDA emphasized that, “Addressing the challenges related to complex generics, and promoting more generic competition to these medicines, is a key part of the FDA’s Drug Competition Action Plan, and the agency’s efforts to promote patient access and more affordable medicines.” The agency notes that it “regularly takes steps to help guide industry through the development process for generic drug products, including combination products, such as MDIs, that consist of a drug and a device” and points out that it published a product specific guidance for budesonide and formoterol fumarate dihydrate inhalation aerosol in June 2015.
FDA Director of the Office of Generic Drugs Sally Choe said, “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. This reflects the FDA’s continued efforts to increase competition and access to quality, safe, effective and affordable medicines for patients and consumers.”
Viatris CEO Michael Goettler commented, “The FDA final approval of Breyna, the first FDA-approved generic version of Symbicort, is an exciting milestone both for our company and the many patients living with asthma and COPD. Our success with this partnership and approval is yet another proof point of the impact of our Global Healthcare Gateway which enables us to join with Kindeva to provide patients in need with new options.”
Viatris President Rajiv Malik added, “The momentous FDA final approval of Breyna is further evidence of our well-established development expertise and proven ability to move up the value chain with more complex products by leveraging our robust scientific capabilities to target gaps in healthcare and patient needs. This approval also builds on our past successes of bringing other complex product firsts to market and demonstrates the continued delivery of our strong pipeline.”
Kindeva Drug Delivery CEO Aaron Mann said, “We are pleased that Viatris has received full FDA approval for this important respiratory product. This important milestone is reflective of our sustained commitment to inhalation and complex drug delivery, from technical formulation, clinical program management, and regulatory submission, and I’m grateful to my many Kindeva colleagues for their contributions.”
Read the FDA press release.
Read the Viatris/Kindeva Drug Delivery press release.
