Out of 503 drugs which have received orphan status from the U.S. Food and Drug Administration, 43 percent of the drugs (217) are open to generic and biosimilar competition, according to a new report from IQVIA, but only 23 percent of the drugs (116) actually face such competition.
“This means just under half of the unprotected products still have not faced competition, some even decades after their exclusivity lapsed,” IQVIA states. “The report additionally finds that it is most often the lapsing of patent exclusivity that enables competition and not the lapsing of orphan drug exclusivity.”
The report, titled “Orphan Drugs in the U.S.,” aimed to assess the orphan drug market since the Orphan Drug Act’s passage in 1983, as well as how prices have changed over time.
Spending on non-exclusive orphan drugs that also aren’t facing generic competition was also modest in 2017, according to the report, reaching just over $100 million.
To read the full report, click here.