Engel, Bucshon Introduce the Advancing Education on Biosimilars Act

Engel, Bucshon Introduce the Advancing Education on Biosimilars Act


Washington, D.C.—Congressmen Eliot L. Engel (D-NY) and Larry Bucshon, M.D. (R-IN) introduced the bipartisan, bicameral Advancing Education on Biosimilars Act of 2019, which would create federal programs to promote the use of use cost-effective biosimilar drugs.  Senators Mike Enzi (R-WY) and Maggie Hassan (D-NH) have introduced companion legislation.


“Biologics are some of the highest priced medications on the market,” said Rep. Eliot Engel. “Yet many health care providers, let alone patients, do not know that cost-effective alternatives known as biosimilars exist in some cases. I’m pleased to join Congressman Bucshon on this commonsense legislation, which will help close this education gap—helping my constituents in the Bronx and Westchester get some relief from the epidemic of high cost drugs.”


“As new biological and biosimilar product options become available, it is important that physicians have current information on these therapies in order to choose the best treatment for their patients. I believe information and education on these new and complex treatments for providers and patients will lead to healthy competition in the biologic and biosimilar product space, and ultimately help to lower the cost of these important drugs for patients,” said Rep. Larry Bucshon.


“Increasing Granite Staters’ and Americans’ awareness of biosimilars will help more people save on prescription drug costs,” said Senator Maggie Hassan. “I am pleased that Representatives Engel and Bucshon have introduced their version of this important bipartisan legislation in the House, and I will continue working across the aisle to move this bill forward in the Senate.”


“I am glad Congressmen Bucshon and Engel introduced companion legislation to our biosimilars education bill in the Senate,” said Senator Mike Enzi. “This legislation would help to drive down drug costs by increasing confidence in cheaper prescription drug alternatives like biosimilars. This can be a great educational tool to help lower health care costs.”


“America’s hospitals and health systems thank Reps. Engel and Bucshon for their bipartisan efforts to facilitate the increased use of biosimilar drugs, including the importance of interchangeability, by educating providers, patients and other key stakeholders on their clinical value,” said Tom Nickels, executive vice president of the American Hospital Association. “This will give patients greater access to affordable, innovative drugs.”


“The Association for Accessible Medicines (AAM) commends Reps. Engel and Bucshon for their work on the Advancing Education on Biosimilars Act. This legislation would direct the FDA to close the education gap and address misinformation about biosimilars for both patients and providers. The International Coalition of Medicines Regulatory Authorities (ICMRA), an executive-level coalition of regulators from 29 medicines regulatory authorities from territories including Australia, Brazil, Canada, China, the European Union, and the United States, recently noted that global stakeholders should be aware that messaging from industry must refrain from misrepresenting the quality, efficacy and safety of biosimilars that have undergone rigorous review by regulatory authorities. Misinformation and a lack of basic understanding about the safety and efficacy of lower-cost biosimilars threaten patient access to these life-saving therapies and cost U.S. billions in lost savings. However, as the gold standard of global regulatory authorities, FDA-approval of a product means that a developer has demonstrated to the agency’s satisfaction that the product is safe and effective. Rebutting misinformation about biosimilars will encourage adoption, reduce patient out-of-pocket costs, and increase patient access,” said Christine Simmon, Executive Director of the Biosimilars Council.


The Advancing Education on Biosimilars Act of 2019 would require the Food and Drug Administration (FDA) to create a public website to educate patients and providers about biological and biosimilar products. This website will include materials about which biologicals and biosimilars may be interchangeable, and processes for reporting adverse events that pose a risk to patient health and safety. To help increase uptake of biologics and biosimilars, this bill would require development of continuing education programs for health care providers such as doctors and nurses.


The Advancing Education on Biosimilars Act of 2019 builds on Congressman Engel’s prior work to address rising drug prices. On August 8, 2019, Rep. Engel introduced the Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act, H.R. 4178, which would enable seniors and the Medicare program to recoup money wasted on oversized drug vials.