First Generic for Dry-eye Gets U.S. FDA Nod

The U.S. FDA announced its approval of the first-ever generic version of Restasis. Restasis is an eye-drops treatment for dry-eye or keratoconjuctivitis sicca. The emulsion is an anti-inflammatory agent that helps to increase tear production. Mylan Pharmaceuticals Inc. scored a big victory as the sponsor of the generic cyclosporine ophthalmic emulsion which is a bioequivalent of Restasis. The generic was developed by Viatris, a company formed by the merger of Pfizer’s off-patent drug developer Upjohn and generic giant Mylan NV. 

Restasis was developed by Allegran and approved for sales in the U.S since 2003. AbbVie acquired Restasis in 2019 in its $63 billion cash-and-stock buyout of Allegran. Restasis is a top-seller and generated over $1 billion revenue in 2021.  

Developing Generic of a Blockbuster Drug

Despite the FDA’s continual attempts to encourage competition and more affordable drugs since 2012, through the Generic Drug User Fee Amendments (GDUFA) program, the road to generic development for Restasis has not been smooth. GDUFA has laid out specific guidelines to define qualitative and quantitative parameters that qualify a product as the bioequivalent drug of Restasis.

Since 2015, Restasis has seen legal battles related to patent infringements, inter partes review and an unusual deal between Allegran and the St.Regis Mohawk Tribe to protect it from the competition. However, the patents were invalidated in October 2017, opening the door for developing cheaper alternatives. 

With as many as 9 generics in the development-and-regulatory-approval pipeline for restasis, Viatris may have a short window of time where it is the sole competition to AbbVie’s top-seller. This announcement may alter AbbVie’s projection of $700 million revenue from Restasis in 2022, “which assumes no generic competition in the first half of 2022.” 

“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 the 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,” said Sally Choe., PhD., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research.

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Author

Sahana Shankar