Biosimilars Forum Statement Regarding Nomination of Dr. Stephen Hahn as Next Commissioner of the Food and Drug Administration (FDA)

WASHINGTON, DC – Ahead of Dr. Stephen Hahn’s Senate HELP committee hearing to be the next FDA Commissioner, the Biosimilars Forum issued the following statement:

The Biosimilars Forum congratulates Dr. Stephen Hahn on his nomination as the next Commissioner of the FDA. If confirmed, Dr. Hahn will play a critical role in ensuring that the FDA leads the way with proactive measures to stimulate our country’s lagging biosimilar market, where only 11 of the 25 approved biosimilars are available to patients. 

Previous FDA commissioners have recognized the urgent need for educating stakeholders and accelerating biosimilar uptake, given that patients and the U.S. health care system at-large could save up to $150 billion over the next decade with increased biosimilar use. It is critical that the FDA continue combating misinformation and anti-competitive practices surrounding biosimilars, as well as reforming regulatory processes to allow for increased competition in the market. 

The Biosimilars Forum looks forward to continuing to work with the FDA to lower health care costs and ensure that patients are able to access the medicines they need.

Dr. Hahn’s confirmation hearing comes amid a series of recent bipartisan biosimilars legislation introduced in Congress, which are projected to save 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 waive 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 as much as $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 enhance provider reimbursement by increasing the ASP add-on payment rate for biosimilars in Medicare Part B. 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 part of the Senate Finance Package in July.

  • Most recently, bipartisan introduction of legislation from Congressmen Paul Tonko (D-NY) and Bob Gibbs (R-OH) would direct the U.S. Department of Health & Human Services (HHS) to create a biosimilar access measure in the Centers for Medicare & Medicaid Services’ (CMS) Star Ratings Program. This measure will help Congress and the industry better understand the barriers that exist to access lower-cost biosimilars in the Medicare Advantage and Part D health plans, allowing for future reforms to the market

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