MedPage Today October 29, 2025
— Biologic “generics” may prompt lower costs, according to some experts
Federal regulators are trying to make it easier to develop cheaper alternatives to biologics that many Americans depend on to treat autoimmune diseases or cancers.
The FDA said Wednesday it has released guidance to simplify studies for biosimilars 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...
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