FDA Reduces Regulatory Red Tape for Biosimilars
The FDA has streamlined biosimilar approvals by eliminating the need for clinical efficacy studies (CESs) for monoclonal antibody biosimilars, relying instead on analytical and PK/PD data.
This change is expected to reduce development costs by 50-60% and shorten timelines by several years.
The move aims to increase competition, lower drug prices, and enhance patient access to biosimilars.