FDA Approves First Generic of Restasis
The FDA has approved the first generic of AbbVie's blockbuster dry eye drug Restasis (cyclosporine ophthalmic emulsion) 0.05%, which generated $1.23 billion in U.S. sales last year.
The agency said it approved the generic Restasis single-use vials from Mylan Pharmaceuticals, which is part of Viatris, the company formed by the 2020 merger of Pfizer's off-patent drugs business Upjohn with generic drugmaker Mylan NV. AbbVie acquired Restasis with its acquisition of Allergan in 2020.
"Restasis has been approved for use in the U.S. for nearly 20 years, but until today, there was no approved generic product of this drug that can help the millions of Americans who suffer from dry eyes," Sally Choe, PhD, director of the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research, said in an FDA news release. "Today's approval reflects the FDA's continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts. Supporting development and expanding opportunities to bring complex generic drugs to the market is a major focus of our efforts to help improve competition and help lower drug prices."
According to FiercePharma, AbbVie Chief Financial Officer Rob Michael said the company expects $2.9 billion in global eye care sales in 2022. That included a $700 million contribution from Restasis, "which assumes no generic competition in the first half of 2022."
In 2017, Allergan sought to protect the patents of Restasis by transferring the them to New York’s Saint Regis Mohawk Tribe, claiming the tribe’s sovereign status made the patents immune from administrative review. However, that transfer was later rejected in the courts.
As part of the GDUFA Science and Research Program, beginning in 2012, the FDA started conducting research to support the development of bioequivalence recommendations for cyclosporine ophthalmic emulsion. In addition to informing the FDA's draft product-specific guidance on cyclosporine ophthalmic emulsion 0.05%, the FDA's research program has helped address complex issues on the analytical measurement and statistical assessment of a proposed generic product to Restasis. To date, the FDA has supported 16 research projects related to cyclosporine ophthalmic emulsion.
The sponsor of the generic cyclosporine ophthalmic emulsion 0.05% single-use vials approved today is Mylan Pharmaceuticals Inc.