Biologics

Bipartisan Biosimilar Access, Affordability Bill Introduced

David McFarland

— 2 min read
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Rep. Nick Langworthy (R-NY) has introduced the Biosimilars Access and Affordability Act, bipartisan legislation that he says would expand access to lower-cost biosimilar prescription drugs and help bring them to market. In a statement, Langworthy says the bill would update Medicare policy to provide a clearer pathway for lower-cost biosimilar medicines that are actively moving toward the market, while protecting Medicare if those competitors never reach patients.

“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,” Langworthy says. “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: 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.”

Langworthy says that 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, he says, it generally operates through separate one-year determinations and has narrow and complicated criteria for qualifying biosimilars.

According to the statement, the bill specifically 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, with an ongoing patent lawsuit alone not disqualifying a biosimilar; and
  • protect Medicare if anticipated competition never arrives by providing that if a biosimilar is not approved and marketed within the two years, 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.

Other House members sponsoring the bill are 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), Kevin Mullin (D-CA), and Jimmy Panetta (D-CA). A companion bill is sponsored in the Senate by Marsha Blackburn (R-TN).

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