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Rep. Nick Langworthy introduced the bipartisan Biosimilars Access and Affordability Act, H.R. 10628, a proposal concerning when a biologic drug may be selected for Medicare price negotiation if a biosimilar competitor is expected. It is not law: the bill was reported as introduced and referred to House committees. Its sponsors say it would clarify the process for a temporary delay while retaining a maximum delay of two years.
What would the bill do?
Under the policy described in Langworthy’s October 2, 2026 announcement, Medicare may temporarily delay selecting an original biologic for price negotiation when a lower-cost biosimilar is expected. The release says current law permits a delay of up to two years through separate one-year determinations and narrow qualifying criteria. The proposed bill would keep that two-year ceiling but establish a clearer route for a biosimilar competitor to qualify for a delay. Langworthy’s release describes the proposal; these mechanics should not be treated as a definitive legal interpretation of the bill text.
Evidence that a biosimilar is approaching
The sponsor’s release says qualifying evidence could include FDA acceptance or approval of an application and required clinical studies that are underway, complete, or deemed unnecessary. Manufacturers would also certify expected launch information and could face legal consequences for knowingly false information. A manufacturer could seek a delay through another pathway by presenting compelling evidence that its biosimilar was highly likely to reach the market. The release says an ongoing patent lawsuit alone would not disqualify a biosimilar.
If the competitor does not launch
If the biosimilar is not approved and marketed within the two-year period, the release says the original biologic would enter Medicare negotiation, and its manufacturer would owe rebates for the period when the negotiated price otherwise would have applied. This is a proposed safeguard described by the sponsor, not an outcome under current law established by the announcement.
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How could it affect Medicare drug price negotiations?
The proposal addresses timing: it aims to allow time for a credible biosimilar competitor to reach the market before Medicare selects the original biologic for negotiation, while discouraging delays based on a competitor that ultimately does not launch. Sponsors argue that a clearer pathway could encourage competition and put downward pressure on costs. The available announcement provides no independently verified estimate of savings or patient impact from this bill, so those effects remain intended outcomes rather than measured results.
Biosimilars are highly similar versions of biologic medicines. 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 statement reflects the sponsor’s rationale, not an independent evaluation of this legislation.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Who sponsors the bill, 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 also says Sen. Marsha Blackburn is leading a Senate companion bill.
Do these 3 things before closing this tab:
1Repair Windows errors before they cause bigger problems2Fix the driver behind crashes, sound loss and screen glitches3Clear out junk files and repair common Windows errorsA LegiScan bill-status record reports that H.R. 10628 was 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 later action. The bill remains a proposal in the status described here; its provisions should not be mistaken for current law.
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