Medical Xpress October 29, 2025
The US Food and Drug Administration said Wednesday it would ease the approvals process for developing replicas of biologic drugs used to treat conditions including autoimmune diseases, cancer and diabetes.
The announced changes would apply to some of the pharmaceutical industry’s most expensive products, medicines engineered with living cells.
The FDA said that developing “biosimilars”—lower-cost alternatives to brand-name biologics—was overwhelmed with red tape, including “unnecessary clinical testing.”
“For too long, government bureaucracy and regulatory barriers have protected monopolies and stifled competition,” said Trump’s health chief, Robert F. Kennedy Jr.
He called the changes an effort to “break down these barriers and open the markets for real competition.”
The move is in line with President Donald Trump’s push to lower drug...
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