Generic drug approvals soar, but patients still go without.
Record numbers of generic drugs have received U.S. FDA approval in recent years. But many of these lower-price medicines haven’t been launched into market. A Wall Street Journal review found that many of the lower-price medicines have not hit the the U.S. market, forcing many patients to continue taking high-priced branded counterparts.
Since 2016, the FDA has approved 2,492 generic versions of 617 brand name drugs. The number of generic approvals has set records each of the past 3 fiscal years, but less than two-thirds of generic drugs approved between 2016 and 2018, or 1,249 of the copies, were launched into the market
Approximately 40% of last year’s 689 approvals have not been launched.
The breakdown is especially acute for the most expensive medicines -- biologic drugs. Biosimilars are also being launched less frequently. Only 11 products are available commercially, despite more than two dozen approvals since 2015.
Many patients are forced to continue on high-price branded medicines, and the widely touted remedy for reining in drug costs via competition and biosimilars has failed to live up to its promise.