Regulatory Focus™ > News Articles > 2020 > 10 > Lack of product-specific guidance slows ANDAs: FDA study

Lack of product-specific guidance slows ANDAs: FDA study

Posted 29 October 2020 | By Kari Oakes 

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.”
For non-NCE drugs, the association between revenue generation and likelihood of ANDA submission was not statistically significant, though CDER researchers saw a similar trend.
Brand-name drug products identified as complex were less likely to have generic submissions, a finding that held true for both NCE and non-NCE drugs. Difficulty in characterizing complex drugs and assessing bioequivalence for complex drugs such as drug-device combination products or those with complex delivery methods may contribute to the lower rate of ANDA submission for complex drugs, said FDA.
Non-NCE drugs were almost four times more likely to have ANDA submissions if a published product-specific guidance was available for the drug, said FDA. Having a product-specific guidance available can give sponsors clarity about methodologic details in developing an ANDA submission, so the CDER researchers recommended prioritizing “timely development” of these guidances.

For NCEs, generic sponsors wasted no time in coming before FDA. “ANDA submissions occurred for more than half of the NCE products within the first two weeks after those ANDAs could be lawfully submitted,” said FDA.
The study found that patents did not significantly affect how likely a reference drugs was to have ANDA submissions, a finding in line with previous research. “[I]n the case of large-revenue drugs…sponsors will challenge the patent even when they are unlikely to win, meaning that higher sales are associated with more pre-generic approval patent challenges (commonly referred to as “Paragraph IV” challenges),” said the researchers.
Recommendations from the researchers focused around having timely product-specific guidance available to generics sponsors. Complex generic drug research should also be prioritized they said. The goal should be to have clarity about best practices before drugs, especially NCEs, are eligible for generic competition. These measures, they said, can help achieve the broader policy goal of increased drug competition and more affordable therapies for patients.



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Tags: FDA, generics, US

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