Federal health officials push effort to spur cheaper biotech drugs
[October 30, 2025]
By TOM MURPHY and MATTHEW PERRONE
Federal regulators are trying to make it easier to develop cheaper
alternatives to powerful drugs that many Americans depend on to treat
autoimmune diseases or cancers.
The Food and Drug Administration said Wednesday it has released guidance
to simplify studies for biologic drugs and cut unnecessary testing.
Biologic drugs are made from living cells instead of by mixing
chemicals. They have led to major advances in treating immune system
disorders, eye diseases and some cancers since the late 1990s, but they
also are very costly.
For decades, biotech drugmakers argued that their medicines were too
complex to be copied by competitors. That finally changed under
President Barack Obama’s 2010 health overhaul, which ordered the FDA to
create a system for approving “biosimilar drugs.” The industry term
arose because scientists insisted it would be impossible to produce
exact copies of their biotech drugs.
FDA’s pathway, finally published in 2015, suggests that drugmakers
conduct studies showing patients respond similarly to biosimilar
versions when compared with the originals.
The latest proposal seeks to ease that standard, which the
administration calls an “unnecessary resource-intensive requirement."
“The result will be more competition, lower prices and faster access to
lifesaving medicines,” said Health Secretary Robert F. Kennedy Jr.
[to top of second column]
|
The Food and Drug Administration seal is seen at the Hubert
Humphrey Building Auditorium in Washington, April 22, 2025. (AP
Photo/Jose Luis Magana, File)
 The draft guidance is the first step
in an extensive bureaucratic process. It amounts to a tentative set
of recommendations for drugmakers.
The FDA will take public comments on its proposal for 60 days. After
that, it must review and revise the document. The final guidance,
expected in three months to six months, will not be binding. It will
serve as suggestions for drugmakers working on biosimilars.
Biosimilar competition has brought some price relief to patients who
take such drugs such as the autoimmune disease treatment Humira. But
this may not happen immediately. That can depend on insurance
coverage and whether the biosimilar is added to a pharmacy benefit
manager’s list of covered drugs.
Experts say that over time, biosimilars also can prompt drugmakers
to lower the cost of their biologic drugs or offer bigger rebates to
keep their product on a formulary.
___
Associated Press writer Ali Swenson contributed to this report.
All contents © copyright 2025 Associated Press. All rights reserved |
