Statement on FDA Announcement on Biosimilar Pathway Reforms

Premier strongly supports the Food and Drug Administration’s proposed reforms to the biosimilar approval pathway—reforms we have long championed to eliminate unnecessary barriers and accelerate patient access to lower-cost medications.

For years, Premier has urged both the FDA and Congress to retire the outdated and confusing statutory interchangeability designation that lacks clinical justification, delays competition and creates unnecessary confusion for providers and patients alike. These common-sense reforms will reduce costs, improve regulatory efficiency and ensure patients benefit from timely access to safe, effective biosimilars.

While the FDA’s proposals are a welcome and long-overdue step forward, they are not binding. Without Congressional action, the status quo will continue to reward gamesmanship over competition. We need more than good intentions. It’s time for lawmakers and federal agencies to act decisively—closing loopholes exploited by insurers and drugmakers—and deliver the enduring and competitive biosimilar marketplace that patients deserve.