Allergan Asks FDA to Revise Guidance Concerning Restasis Generics


Allergan, Inc., has asked the FDA to revise its draft guidelines that state that a human clinical trial would not be necessary for a generic drugmaker to establish bioequivalence for Allergan's dry eye disease drug Restasis (cyclosporine ophthalmic emulsion 0.05%), assuming the active ingredient is the same. The FDA opened the door to early generic competition for Restasis when it released this guidance in June. In it, the agency stated, “It does not appear that conducting a bioequivalence study with clinical endpoint for this drug product would be feasible or reliable due to the modest efficacy demonstrated by the Reference Listed Drug.”

In response, Allergan posted a 43-page letter on its website stating, “The Draft Guidance recommends that in vitro analyses alone be submitted to establish that a proposed generic drug product is bioequivalent to Allergan’s Restasis (cyclosporine) ophthalmic emulsion, 0.05% w/v (“Restasis”). For reasons explained below, that proposal is unsound both scientifically and legally. Allergan therefore requests that FDA replace the Draft Guidance with a revised guidance document that explains in vivo comparative clinical studies are required to demonstrate that a proposed generic product is bioequivalent to Restasis.”

Restasis, which was approved in the United States in 2002, is Allergan’s second-best-selling drug, behind Botox. The former is expected to generate sales of $850 to $890 million in 2013.


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