Rep. Nick Langworthy introduced the bipartisan Biosimilars Access and Affordability Act, H.R. 10628, to clarify when Medicare may temporarily delay selecting an original biologic drug for price negotiation while a biosimilar competitor is expected to reach the market. It is a proposal, not current law, and no bill-specific savings estimate has been established.
What would the bill do?
Biologics are medicines made from living systems; biosimilars are highly similar versions that can add treatment choices and competition. The bill concerns the timing of Medicare price negotiations for an original biologic when a biosimilar is approaching market—not a general change to drug prices or a guarantee that a lower-cost alternative will launch.
According to Langworthy’s October 2, 2026 announcement, current policy can delay selection of an original biologic for negotiation for up to two years when a qualifying biosimilar competitor is expected. The release describes the current process as relying on separate one-year determinations and narrow eligibility criteria. The proposal would retain the two-year maximum while setting out a clearer route for qualifying competitors to support a delay. These descriptions of current policy and proposed mechanics are the sponsor’s account; the introduced bill text should be consulted for an authoritative legal interpretation.
What evidence would support a delay?
The sponsor’s release says a biosimilar could qualify with evidence that the FDA has accepted or approved its application and that required clinical studies are underway, completed, or have been determined unnecessary. Manufacturers would also certify expected launch information and could face legal consequences for knowingly false information.
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The release describes another route for a manufacturer to seek a delay by presenting compelling evidence that its biosimilar is highly likely to reach the market. An ongoing patent lawsuit, by itself, would not disqualify the biosimilar under the proposal as described by the sponsor.
What if the biosimilar does not launch?
Under the sponsor’s description, if the biosimilar is not approved and marketed within the two-year delay, the original biologic would enter Medicare price negotiation. Its manufacturer would owe rebates covering the period in which the negotiated price otherwise would have applied. This proposed safeguard is meant to address the possibility that a delay is granted but the expected competitor never reaches patients; it is not an existing obligation created by this bill unless the proposal becomes law.
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Who introduced it, and what is its status?
Langworthy announced the bill on October 2, 2026. The 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 any later action.
The announcement lists Reps. Jake Auchincloss, John Joyce, Linda Sánchez, Scott Peters, Rudy Yakym, Nathaniel Moran, Kevin Mullin, and Jimmy Panetta as House cosponsors, and says Sen. Marsha Blackburn is leading a Senate companion bill.
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What is known about potential savings?
The sponsors argue that clearer rules could encourage biosimilar competition and help put downward pressure on costs. Langworthy said in the announcement: “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 legislation.
No independently verified estimate of savings or patient impact specific to H.R. 10628 is established here. The practical effect would depend on whether the proposal becomes law, which products qualify, and whether expected biosimilar competitors actually launch.
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