Despite Record Number of Generic Drug Approvals, Many Are Not Yet Available in the U.S.

Generic drugs

Over the past several years, there have been a record number of generic drug approval. Despite that plethora of generic medications, less than two-thirds of the medications are on the market in the United States.

A new report from The Wall Street Journal showed that two-thirds of the generics approved between 2016 and 2018 are now in the hands of consumers. Less than 30% approved last year are now on the market, according to the Journal. The culprit, according to the report, is the legal system. Many of the drugs that have been approved are involved in lawsuits over things like patent infringement.

With many of the generics not yet hitting the market that means more patients are having to remain on the more expensive branded drugs. The hope had been that the flood of generics would lower the burden of high-price drugs that many people face.

According to the report, since 2016 there have been 2,492 generic drugs approved by the U.S. Food and Drug Administration. Despite that high number of approvals, only 1,249 of the drugs have been launched, the Journal said, citing Iqvia. A huge number of generic drugs approved in 2018 have yet to be launched and only 134 of the 442 generic drugs approved from through June of this year are available for patients.

Expedited approval of generic drugs has been a hallmark of the White House’s efforts to lower the high cost of drugs many Americans face. Generic approval has also been championed by other lawmakers, particularly as the price of many branded drugs increase. During the first half of 2019, pharma companies raised the list price of branded drugs by an average of 5%. While prices have gone up, the increase amounts are actually lower than in previous years when the average price hike was about 9%.

In its analysis, the Journal also noted that many biosimilar drugs approved for use in the United States have not been launched yet. The first biosimilar was approved for use in the U.S. in 2015. Since then, the FDA has green lit about two-dozen, the Journal said. But, only 11 of those are now commercially available. And that’s primarily due to legal issues, such as patents. For example, there have been multiple Humira biosimilars approved by the FDA but that drug’s patent protection does not expire in the U.S. until 2023. So, those biosimilar products are not being used. Just this week, Pfizer won approval for Abrilada, a Humira biosimilar but it will not be sold in the U.S. until that Humira patent expires.

Even when some generics are on the market, they may still not get into the hands of patients with tight finances. In May, Eli Lilly launched an authorized generic version of its insulin Humalog with a 50% cheaper price tag. But, in August, BioSpace reported that many of the pharmacies across the U.S. were still filling prescriptions for the branded product. One reason for that lack of use of the generic version may be a lack of awareness that the product is available. Another is the fact that some insurers are not yet covering the generic.  

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