AAM welcomes FDA plan to simplify biosimilar approvals

The Association for Accessible Medicines and its Biosimilars Council have welcomed a US regulator plan to simplify biosimilar approvals. Food and Drug Administration Commissioner Martin Makary announced the changes at AAM’s GRx+Biosims 2025 meeting, describing the move as part of the Trump administration’s drive to lower drug costs.

The policy would remove the interchangeability designation and replace clinical efficacy studies with more analytical assessments. AAM president John Murphy said the changes would eliminate costly hurdles, while policy head Alex Keeton called the designation outdated. Industry advocates have long argued that it delays patient access and discourages investment.

Biologics account for about half of total US drug spending but only a small share of prescriptions. Biosimilars currently represent roughly $22.6 billion in sales, and analysts expect the market to grow to about $93.5 billion by 2034. Officials hope the reforms will close the adoption gap with Europe, where interchangeability rules do not exist.