Viatris' copycat to AstraZeneca blockbuster Symbicort passes FDA muster, but legal battle delays launch

Viatris appears to be on a roll with "complex generic" approvals. Just a month after its Restasis copycat nod, the company has scored the first FDA approval for a generic to AstraZeneca's big-selling Symbicort, teeing up a potential launch later this year.

The FDA approved Viatris and Kindeva Drug Delivery's Breyna, a drug-device combination product, in certain patients with asthma or chronic obstructive pulmonary disease. The drug shouldn't be used to treat acute asthma attacks, the FDA said.

Following the approval, Viatris said it may be able to launch this year, depending on the outcome of court proceedings.

On that front, AstraZeneca sued Viatris' Mylan Pharmaceuticals back in 2018 for alleged infringement. Last March, a district court ruled in favor of AstraZeneca, prompting the generics partners to appeal. Then in December, the U.S. Court of Appeals for the Federal Circuit reversed the infringement judgment and sent the case back down to the lower court for more proceedings. 

Since the potential legal outcome is unknown, Viatris doesn't appear to have a firm launch timeline yet. 

Symbicort pulled in $2.7 billion globally last year, making it a top target for generics makers worldwide. Sales in the U.S. came in at just above $1 billion.

For Viatris, which formed in 2020 as a combination of Mylan and Pfizer's Upjohn, the approval is the second "complex generic" nod in as many months. Last month, the company scored approval for its copycat to AbbVie's eye drug Restasis, allowing it to launch shortly after. 

Viatris says the approval also marks a win in its "Global Healthcare Gateway" ambition. Through that strategy, the company aims to partner with other drugmakers to bring various products to new markets by using its regulatory experience around the globe.