FDA Approves First Restasis Generic

February 18, 2022

The FDA has approved the first generic version of Restasis, according to a press release.

Cyclosporine ophthalmic emulsion 0.05% increases tear production in patients with dry eye disease. The generic option is sponsored by Mylan Pharmaceuticals.

“Restasis [Allergan] 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 the 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.”


Francis S. Mah, MD

I think there are several aspects to this approval. The obvious No. 1 aspect is that there is going to be another medication that we are going to have as clinicians and for patients who have dry eye disease to be able to use in our armamentarium, and hopefully the access will be a little bit easier with having a generic.

Having said that, I don’t know that the overall, for example, MSRP of the generic drug is going to change a whole lot with one generic. In general, if there is one generic, they are probably going to price it, MSRP-wise, relatively similarly to the branded medication. Maybe several dollars, hopefully several tens of dollars, hopefully several hundreds of dollars cheaper. My guess is the price will be similar for now, so if there is a cash-paying patient, if there is someone who does not have drug coverage, I don’t know that it is going to make a huge impact MSRP-wise.

We now have another drug FDA approved for dry eye disease. It is a generic of something that has already been available, and two of the FDA-approved, branded medications actually have the same key ingredient. I think the main thing that it will do is hopefully improve access, but it may channel people into using the generic before having access to the other medications, if previous experience with generics is any indication of what will happen with access.

From the business side, and this does not really affect us as providers and/or patients per se, but obviously Allergan/AbbVie was surprised by this FDA decision. From a company standpoint, that may change some of its financial outlooks and, therefore, investments in possible short-term innovation.

In general, I think it is great that we have another drug, and hopefully this will improve access for patients.

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