Generic drug development has become a big business in recent years. All sorts of companies in the biopharmaceutical arena are now vying to get their generics approved for market use. And, although innovator product manufacturers are often against generic development, as it leads to competition for their products, having more generic drugs on the market is a good thing for consumers.
Generic drugs are only approved for use after tests have shown that they are bioequivalent to the Reference Listed Drug (RLD). This means that the generic and the RLD have the same active ingredient, and that active ingredient has the same rate and extent of absorption in both products.
Bioequivalence, therefore, ensures that an RLD and a generic work in exactly the same way and are interchangeable products. This allows patients to buy either drug, knowing that one will have the exact same effect as the other. Giving patients more choice means the price of expensive innovator products will have to fall to allow the product to remain competitive.
So more choice, and cheaper choices, that’s what generic drugs provide.
However, the US Food and Drug Administration (FDA) approval rate for generic drugs has slowed in the past months. In fact, data released in June of this year revealed that FDA rejections of Abbreviated New Drug Applications (ANDAs) for generic drugs had reached an all-time high in the month ending in mid-April.
To give some real facts and figures, by mid-June of 2016, the FDA had already rejected 879 ANDAs, with five months still left to report. If you compare this to the 1180 rejections made in the whole of 2015, it is not difficult to see that the numbers are up significantly.
When asked to explain this increase in ANDA rejections for generic drugs, the FDA declined to comment. According to the agency there are a variety of reasons why the number of rejections can increase drastically, but there is no way speculate what the specific causes are over such a short period of time.
Whatever the reasons behind the increase, it will be interesting to see how the rest of the year plays out with regard to FDA approval ratings.