Overview
- The draft guidance would allow developers to rely on advanced analytical testing instead of routine comparative human efficacy studies for many biosimilars.
- The FDA also plans to stop generally recommending switching studies for interchangeability, easing pharmacist substitution where state law permits.
- Officials estimate the changes could cut development timelines roughly in half and save about $100 million per biosimilar product.
- Despite 76 U.S. biosimilar approvals, market share remains under 20% while biologics account for about 5% of prescriptions yet over half of drug spending.
- Biosimilar makers and PBM groups praised the move, as analysts cautioned that patents, PBM contracts and formulary decisions will continue to limit uptake.