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The head of the ERISA Industry Council — a group that represents self-insured employers — says a new Trump administration initiative could help bring down the cost of some of the most expensive drugs now on the market.
James Gelfand, the president of ERIC, said draft guidance the U.S. Food and Drug Administration posted Wednesday could create new competition for "biologic" medications.
Biologic drugs are medications created using living organisms, such as yeast or blood cells, rather than through the kinds of simpler chemical processes that people can manage.
The FDA proposed eliminating some biologic product testing requirements.
The release of the new FDA draft guidance "is a huge step toward removing barriers that for too long have delayed and prevented competition to biosimilars," Gelfand said in a statement issued by ERIC.
Biologic and biosimilar medications: The 600 biologic medications now available in the United States cost U.S. patients an average of about 20 times more than other types of drugs.
One reason biologic drug prices are high is that the FDA has approved only 76 "biosimilar" drugs, or generic versions of biologic drugs, according to the FDA.
"Only about 10% of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development," officials said.
The FDA draft: The FDA wants to eliminate some types of biosimilar drug testing requirements, such as requirements that biosimilar drugs go through processes comparing their efficacy with the efficacy of the drugs already on the market.
Gelfand's view: "There are few issues where agreement is louder than when you ask Americans whether policymakers ought to do more to lower the cost of prescription drugs," Gelfand said.
The new draft reflects the efforts ERIC has been making to understand biosimilars since 1960, ERIC said.
"Through this work, ERIC found that biosimilars saved employers, employees, and their families significant amounts of money, with the potential for much greater savings," ERIC said.
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