Washington DC - The 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 prices, which have included negotiations with individual pharmaceutical companies and the development of a direct-to-consumer website for certain drugs called TrumpRx.
The FDA said in a statement that biologic medications make up 5% of US prescriptions but in 2024 accounted for 51% of total drug spending.
While generic drugs – which are chemically developed – are in essence direct copies of their brand-name counterparts, that's not the case for biologic medications.
The FDA said it would simplify biosimilarity studies and also make it easier for biosimilars to be licensed as "interchangeable."
FDA eases process for developing replicas of biologic drugs
Currently, demonstrating interchangeability – a classification that gives pharmacists license to substitute a biosimilar without first consulting the prescriber – frequently requires comparative clinical trials that analyze patients receiving the reference drug and others who receive the reference and a biosimilar.
The FDA says those are resource- and time-intensive and no longer recommended, and that analytical testing is enough.
"Science continues to evolve, and the FDA remains committed to advancing common-sense policies that further promote efficient and effective biosimilar and interchangeable biosimilar development, without compromising safety and effectiveness," said George Tidmarsh, the FDA's director of drug evaluation and research, in a statement.