Rep. Nick Langworthy introduced a bipartisan bill Friday that would change when Medicare can postpone price negotiations for an expensive biologic drug while a competing biosimilar is headed to market.
The Biosimilars Access and Affordability Act would retain the current two-year maximum delay but change the evidence manufacturers can use to qualify, according to a release emailed by Langworthy's office. Sen. Marsha Blackburn, a Tennessee Republican, is leading a companion measure in the Senate. The proposal has not become law.
Biosimilars are medicines the Food and Drug Administration has found to be highly similar to an approved biologic, with no clinically meaningful differences in safety or effectiveness. Biologics include treatments for cancer and autoimmune diseases. Biosimilar competition can lower costs, but the bill would not itself set a price or guarantee savings for any patient.
The measure concerns a narrow exception in Medicare's drug-price negotiation program. Under current Centers for Medicare & Medicaid Services guidance, the agency may temporarily delay selecting an original biologic for negotiation when there is a high likelihood that a biosimilar will be licensed and marketed within two years. Existing rules require an accepted or approved FDA application and evidence supporting the expected launch.
What the proposal would change
Langworthy's office said the bill would create a more predictable path to the full two-year delay rather than relying primarily on separate one-year determinations. A manufacturer could point to an FDA-accepted or approved application and required clinical studies that are underway, finished or deemed unnecessary. The release also describes an alternative for a manufacturer with compelling evidence that its biosimilar is likely to reach the market, even if patent litigation is pending.
Manufacturers would have to certify their expected launch information and could face legal consequences for knowingly false claims, the office said. If the anticipated biosimilar is not approved and marketed by the end of the two-year period, the original biologic would enter Medicare's negotiation program. Its manufacturer would owe rebates for the time a negotiated price otherwise would have applied, according to the release.
Those provisions attempt to balance two competing risks: negotiating the original drug just before a lower-cost competitor arrives, or delaying negotiation for a competitor that never reaches patients. Whether the changes would increase biosimilar launches or reduce what patients pay remains untested.
Regional connection and next steps
Roswell Park Comprehensive Cancer Center in Buffalo supports the measure. President and CEO Candace Johnson said in Langworthy's release that access to effective cancer treatments and affordability matter to patients. The center did not provide an estimate of how the bill would affect its patients or costs.
Langworthy, whose district includes parts of the Southern Tier, said the bill would give biosimilars that are genuinely moving through the FDA process an opportunity to compete while preventing Medicare from waiting indefinitely. Other House lawmakers listed as co-leaders include Democrats Jake Auchincloss, Linda Sánchez and Scott Peters and Republicans John Joyce, Rudy Yakym and Nathaniel Moran.
The release did not provide a bill number or a Congressional Budget Office cost estimate. It also did not specify when either chamber might consider the legislation. Congress would have to pass the measure and the president would have to sign it before its proposed rules could take effect.
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