USA – Lack of product-specific guidance slows ANDAs: FDA study

Researchers at the US Food and Drug Administration (FDA) found that, for drugs that are new chemical entities, generic submissions were more likely when the reference brand-name drug generated more revenue.

Looking into other factors that predict that an abbreviated new drug application (ANDA) will be filed for a reference drug, the investigators also found that sponsors were less likely to file ANDAs for complex drugs.

In a retrospective study examining 400 brand-name drugs eligible for ANDA filing between 2011 and 2017, investigators at FDA’s Center for Drug Evaluation and Research (CDER) identified 140 that had originally been approved as new chemical entities (NCEs).

Among the NCEs, said FDA, “if market exclusivity resulted in annual revenues greater than $250 million for up to a four-year period after the approval date, an ANDA submission for the given reference product was nearly four times more likely to be submitted than for a product generating sales of less than $10 million.”…