The FDA announced steps to speed the development of lower-cost biosimilars and reduce prices, and it ties these actions directly to new FDA draft guidance.
“The U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines,”
The new draft guidance pivots away from routine comparative efficacy trials and toward sensitive analytical assessments, trimming timelines and costs while keeping standards intact—this policy shift is explicitly due to the FDA’s draft guidance.
“In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing,”
To make substitution easier for patients and pharmacists, the agency also indicates that separate “switching studies” for interchangeability generally won’t be recommended—another change stemming from the draft guidance.
“The FDA now generally does not recommend switching studies,”
The FDA underscores why the change matters: biologics are a small slice of prescriptions but a dominant share of spending, and while dozens of biosimilars exist, overall uptake and competition remain limited—hence the fresh draft guidance to spur market entry.
“Biologic medications make up only 5% of prescriptions… but account for 51% of total drug spending… To date, FDA has approved 76 biosimilars,”
Officials emphasize that the policy aims to expand options and intensify competition without sacrificing rigor, explicitly grounding the shift in the new draft guidance.
“Science continues to evolve, and the FDA remains committed to advancing common-sense policies… without compromising safety and effectiveness,”
With the draft guidance, the agency aims to help more companies bring affordable, high-quality biosimilars to market and reduce costs for patients.
“With today’s action, the FDA aims to help more companies bring affordable, high-quality biosimilars to market and reduce costs for the American people,”