- AbbVie may soon face competition for its top-selling eye drug Restasis after the Food and Drug Administration on Wednesday approved a generic version.
- FDA officials have wrestled with the regulatory path for generic Restasis for years, beginning a research project in 2012 to help spur development of a copycat version and guide drugmakers. According to analysts with Evercore ISI, at least nine generic companies have sought FDA approval of their versions, but Viatris is so far the only one to cross the finish line.
- It's unclear when Viatris will launch its version and how long it will have the generic market to itself. The company hasn't put out a statement on the FDA's action, and a spokesperson didn't return a request for comment from BioPharma Dive.
The approval comes as a something of a surprise. Back in 2020, big generic companies were telling investors the FDA could clear a copycat version of Restasis "any day," but then stopped talking about it as the agency failed to act, Evercore analyst Umer Raffat wrote in a note to investors.
Viatris, formed from the merger of Mylan and Upjohn in 2019, appears to have what it needs to launch a generic, with plenty of supply and manufacturing in place, Raffat said. The company could earn a few hundred million dollars if it has the only generic on the market for the rest of the year, he added.
AbbVie certainly wasn't expecting generic competition this soon, telling investors Wednesday morning that its sales estimates for Restasis assumed no rivals in the first half of 2022. The drug, used to treat dry eye disease, generated $1.2 billion in sales for AbbVie last year.
AbbVie gained Restasis in its $63 billion purchase of Allergan in 2019. Over the years, Allergan went to extraordinary lengths to protect its Restasis franchise, at one point giving patent rights to the St. Regis Mohawk Tribe in an attempt to derail patent challenges. The plan didn't work.