Congressman Langworthy Introduces Bipartisan Biosimilars Access & Affordability Act

October 2, 2026 Press Release Legislation to expand access to lower-cost biosimilar prescription drugs Washington, D.C. —October 2nd… Congressman Nick Langworthy today announced the introduction of the Biosimilars Access and Affordability Act, bipartisan legislation to expand access to lower-cost biosimilar prescription drugs and help bring them to market. The legislation updates Medicare policy to provide a clearer pathway for lower-cost biosimilar medicines that are actively moving toward the market, while protecting Medicare if those anticipated competitors never reach patients. Senator Marsha Blackburn (R-TN) is leading the companion bill in the U.S. Senate. Biosimilars are highly similar versions of biologic medicines that can provide additional treatment options and introduce competition into markets where patients may have limited choices. By encouraging legitimate biosimilar competition, the legislation aims to expand access to treatments and help put downward pressure on drug costs. “Competition is one of the most powerful tools we have to drive innovation and affordability in our healthcare system and biosimilars have helped give millions of patients access to lifesaving drugs at lower costs,” said Congressman Nick Langworthy. “But time is of the essence when dealing with a disease or illness and patients should not have to pay more simply because a lower-cost competitor is on the way, but the rules governing Medicare don't adequately account for it. Our legislation takes a straightforward approach that if a biosimilar is genuinely moving through the FDA process and toward the market, it should have a fair opportunity to compete. At the same time, Medicare should not be left waiting indefinitely if that competition never materializes. This is good for patients, good for research and development, and good for the Medicare system.” Under current law, Medicare can temporarily delay selecting an original biologic drug for price negotiation when a lower-cost biosimilar competitor is expected to enter the market. While the existing policy can allow for a delay of up to two years, it generally operates through separate one-year determinations and has narrow and complicated criteria for qualifying biosimilars. The Biosimilars Access and Affordability Act would maintain the existing two-year maximum while creating a clearer and more predictable process for determining when an approaching biosimilar qualifies for the temporary delay. Specifically, the legislation would: Simplify the existing two-year delay process by establishing a clearer pathway for qualifying biosimilars rather than relying primarily on separate one-year determinations. Recognize concrete evidence that a biosimilar is moving toward the market, including FDA acceptance or approval of an application and required clinical studies that are underway, completed or determined to be unnecessary. Require manufacturers to certify their expected launch information, with legal consequences for knowingly providing false information. Preserve another pathway for strong cases, allowing a manufacturer to seek a delay when it can provide compelling evidence that its biosimilar is highly likely to reach the market. An ongoing patent lawsuit alone would not disqualify a biosimilar. Protect Medicare if anticipated competition never arrives. If a biosimilar is not approved and marketed within the two-year period, the original biologic would enter Medicare's negotiation program, and its manufacturer would owe rebates covering the period during which the negotiated price otherwise would have been in effect. The legislation is also co-led by Reps. Jake Auchincloss (D-MA), John Joyce (R-PA), Linda Sánchez (D-CA), Scott Peters (D-CA), Rudy Yakym (R-IN), Nathaniel Moran (R-TX) as well as original cosponsors, Rep. Mullin (D-CA) and Rep. Panetta (D-CA). Rep. Jake Auchincloss said, “Healthcare premiums are too expensive — going up by more than 10% for employees in Massachusetts. Bringing more biosimilars to market helps lower those premiums for Bay Staters.” "This legislation provides certainty for the future development of biosimilars,” said Rep. Nathaniel Moran. “Biosimilars are vital to our healthcare ecosystem as they provide lower-cost options for patients and produce significant savings for taxpayers. East Texans deserve access to lower drug prices, and I'm glad to co-lead this with Congressman Langworthy.” “As a physician legislator, I know that innovation is the cornerstone of American medicine,” said Congressman John Joyce, M.D. “Maintaining incentives to develop and bring biosimilars to the market helps deliver effective treatments to patients at a lower cost. This legislation is a pro-patient and pro-innovation solution to a harmful consequence of the IRA drug pricing negotiation program.” Congressman Scott Peters said, “Biologics are critical to treating serious illnesses like cancer, autoimmune diseases and genetic disorders, but they are also some of the most expensive drugs on the market. Biosimilars have cut biologic prices by up to 85 percent, yet only a small fraction of name-brand biologics have biosimilars in development. Our bill preserves the biosimilar pathway while incentivizing new development. Red tape should not stand between patients and affordable access to the cutting-edge treatments they need.” The Biosimilars Access and Affordability Act is supported by the Alliance for Aging Research, Arthritis Foundation, Eosinophilic & Rare Disease Cooperative, Community Access National Network, Global Healthy Living Network, International Cancer Advocacy Network, International Pemphigus and Pemphigoid Foundation, Lupus and Allied Diseases Association, Inc., and Roswell Park. “For people facing cancer, access to the right treatment at the right time is incredibly important. Roswell Park is grateful to Congressman Langworthy for his leadership in advancing this smart proposal to expand access to effective cancer therapies while improving affordability for patients and our health care system.” --Candace S. Johnson, PhD, President and CEO, Roswell Park Comprehensive Cancer Center “Biosimilars play an increasingly effective role in the fight against cancer and greatly help with the side effects of treatment.  The Biosimilars Access and Affordability Act will increase the number of biosimilars available and reduce costs for patients.  It's an important bill which all people fighting cancer and other lethal and chronic diseases should strongly support.” --Marcia K. Horn, JD, President and CEO, ICAN, International Cancer Advocacy Network “Patients living with eye disease deserve to be at the center of every treatment decision, with access to the full range of safe, effective and affordable options available to them and their providers. Biosimilars can play an important role in expanding access and affordability, but lower cost should never come at the expense of effectiveness, patient outcomes, or the ability to choose the treatment that is right for them. Prevent Blindness supports policies that put patients first—expanding access and choice today while preserving the innovation necessary to develop the sight-saving treatments of tomorrow.” -- Kira Baldonado, Executive Vice President of Prevent Blindness "For people managing a rare disease, access isn't abstract — it's not just about the medicine that is keeping them stable now, but what is next. Biosimilars are an important part of the treatment landscape, and we should prioritize access to all treatment options." – Sarah Jones, Eosinophilic Rare Disease Coalition Casey McPherson, Executive Director of the Alliance for Patient Access said, “Biosimilars give patients and physicians more affordable options for treating serious and chronic conditions. But unclear rules around Medicare's biosimilar delay provision are discouraging the investment needed to bring these treatments to market. The Biosimilars Access and Affordability Act restores the law's original intent with clear, predictable standards. The Alliance for Patient Access is proud to support this legislation."