Biosimilars Forum Congratulates Dr. Stephen Hahn on Confirmation to Lead the Food and Drug Administration (FDA)

WASHINGTON, DC – Following Dr. Stephen Hahn’s successful confirmation as the incoming FDA Commissioner, the Biosimilars Forum issued the following statement:

The Biosimilars Forum congratulates Dr. Stephen Hahn on his confirmation as the next Commissioner of the FDA. His leadership will play a critical role in advancing biosimilars as a safe and cost effective treatment option to treat many prevalent and challenging diseases, including cancer, rheumatoid arthritis, and Crohn’s disease. Decisionmakers on both sides of the aisle must recognize the urgent need to support a robust biosimilars market in the U.S. in order to safely and effectively lower treatment costs. We look forward to working with Dr. Hahn and the FDA to translate urgency into action.

Dr. Hahn’s confirmation comes amid the introduction of a series of bipartisan biosimilars legislation aimed at saving patients and the health care system at-large, billions of dollars, annually:

• Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act by Congressmen Scott Peters (D-CA), Pete King (R-NY) and Anthony Brindisi (D-NY). This bipartisan bill would eliminate patients’ out-of-pocket costs for biosimilars under Medicare Part B. A recent analysis showed that this can save up to $5.2 billion in taxpayer dollars over ten years and that seniors in Medicare can save up to $3.3 billion in out-of-pocket costs over the same period.

• Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act by Congressmen Kurt Schrader (D-OR) and Greg Gianforte (R-MT) would temporarily enhance provider reimbursement by increasing the ASP add-on payment rate for biosimilars in Medicare Part B. Incentivizing biosimilars use through an increased ASP add-on could reduce health care costs by as much as $8.2 billion over the next decade. A similar bill was introduced as a part of the Senate Finance Package in July.

• Star Rating for Biosimilars Act by Congressmen Paul Tonko (D-NY) and Bob Gibbs (R-OH) would direct the U.S. Department of Health & Human Services (HHS) to create a biosimilars access measure within the Centers for Medicare & Medicaid Services’ (CMS) Star Ratings Program. This measure will help to identify barriers to accessing lower-cost biosimilars as a part of Medicare Advantage and Part D health plans, providing an opportunity to improve plan performance and access.

To learn more about these money-saving policies and the Biosimilars Forum, click here.