Rep. Nick Langworthy’s bipartisan Biosimilars Access and Affordability Act is a proposal—not law—to change when Medicare can select an original biologic drug for price negotiation while a lower-cost biosimilar competitor is approaching the market. Its sponsors say it would clarify the route to a temporary delay, keep the existing maximum at two years, and require rebates if the anticipated competitor fails to reach the market in time.
What would Langworthy’s bill change?
The proposal concerns Medicare’s selection of an original biologic for price negotiation when a biosimilar competitor is expected. According to Langworthy’s October 2, 2026 announcement, current policy can temporarily delay selection for up to two years, but relies on separate one-year determinations and narrow qualifying criteria. The bill would retain that two-year maximum while providing a clearer process for qualifying biosimilar competitors. These are the sponsor’s descriptions of current policy and the proposal; the bill has not been enacted.
What evidence would a biosimilar need to qualify?
Langworthy’s release describes several types of evidence and conditions for a requested delay:
- The Food and Drug Administration has accepted or approved the biosimilar application.
- Required clinical studies are underway, completed, or have been determined unnecessary.
- The manufacturer certifies expected launch information. The release says knowingly false information would carry legal consequences.
- A manufacturer could seek a delay through another pathway by offering compelling evidence that its biosimilar is highly likely to reach the market.
- An ongoing patent lawsuit alone would not disqualify a biosimilar.
These mechanics are based on the sponsor’s release, not an independently verified legal analysis of the introduced bill text.
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What if the biosimilar does not launch?
Under the release’s description, if the biosimilar is not approved and marketed within the two-year period, the original biologic would enter Medicare price negotiation. Its manufacturer would also owe rebates covering the period when the negotiated price otherwise would have applied. The release presents this as a safeguard against a delay based on competition that does not materialize; it is a proposed remedy, not a current requirement under this bill.
Who sponsors the proposal, and what is its status?
Langworthy’s announcement names him as sponsor and Reps. Jake Auchincloss, John Joyce, Linda Sánchez, Scott Peters, Rudy Yakym, Nathaniel Moran, Kevin Mullin, and Jimmy Panetta as House cosponsors. It says Sen. Marsha Blackburn is leading a Senate companion bill.
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A LegiScan status record lists H.R. 10628 as introduced on September 28, 2026, and referred to the House Energy and Commerce and Ways and Means Committees. That is a dated status snapshot, not confirmation of the bill’s status today. The bill record identifies H.R. 10628 as an amendment to Title XI of the Social Security Act concerning when biosimilar biological products are eligible for Medicare price negotiations: LegiScan’s H.R. 10628 record.
What could the proposal mean for patients and costs?
Biosimilars are highly similar versions of biologic medicines. They can expand treatment choices and introduce competition. Langworthy’s release argues that a clearer pathway could encourage biosimilar competition and put downward pressure on costs. It does not establish a bill-specific savings estimate or patient outcome, so the proposal should not be described as having already reduced drug costs.
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In the release, Langworthy said: “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.” That is the sponsor’s rationale, not an independent evaluation of this bill.
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The detailed mechanics above come from the sponsor’s October 2, 2026 release. The introduced bill text and its current status were not independently verified here, so readers should treat the release’s account as a description of the sponsors’ proposal rather than a definitive legal interpretation. The release identifies the original House announcement at Langworthy’s official-site announcement.
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