Bill speeds up approval of generic complex drugs.
H.R. 9661 — Expedited Access to Biosimilars Act · Filed by Nicholas Langworthy (R-NY) · 2 cosponsors · Introduced Jul 14, 2026 · Referred to committee
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What it does
The bill changes how the FDA approves biosimilars. Biosimilars are generic versions of complex drugs. Right now, companies must do expensive studies. This bill says companies only need to show molecular similarity. The FDA can still require more studies. It must write down why and notify the company.
Who it affects
Patients could get cheaper complex drugs faster. Drug companies that make biosimilars could launch sooner. Companies that make original drugs face faster competition.
One thing to notice
The bill shifts the burden to the FDA. Instead of companies proving their drug works, the FDA must prove it needs more proof.
From the analysis of the bill text, linked under Primary records below.
Where it stands
2 cosponsors: 1 Democrats, 1 Republicans.
- Jul 14, 2026 — Introduced · Congress.gov: “Introduced in House”
- Jul 14, 2026 — Referred to House Committee on Energy and Commerce · Congress.gov: “Referred to the House Committee on Energy and Commerce”
Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.
Money around this bill
3 groups reported lobbying about this bill. They filed 3 reports from Jun 2026 to Jun 2026.
Those reports show $8,210,000 in lobbying spending. Each report lists about 40 bills. So that money was not all for this bill.
More groups named this bill than 61% of bills with any report.
Nicholas Langworthy, who sponsored the bill, received $1,031,415 from PACs for the 2026 election.
- Pharmaceutical Research and Manufacturers of America — $7,360,000 in 1 report
- Blood Cancer United (fka the Leukemia & Lymphoma Society) — $590,000 in 1 report
- American Society of Health-system Pharmacists — $260,000 in 1 report
Lobbying is legal. These reports show who lobbied about this bill, not what changed.
Words to know
- biosimilar — A generic version of a complex drug made from living cells.
- FDA — The government agency that approves drugs before they can be sold.
- lobbying — Trying to influence lawmakers about a bill. Companies and groups pay people to do this.
- PACs — Groups that collect money and give it to candidates for office.
- sponsored — To sponsor a bill is to introduce it in Congress and put your name on it.
How this was measured
Analysis — Quorum's AI read the bill text published by Congress.gov (2,300 characters) on Aug 12, 2026. Section numbers in the findings refer to that text, linked below; transparency and hidden-provision scores are compared against the median of 14,707 analysed bills.
Status and sponsors — Congress.gov's bill record — actions, committee referrals and cosponsors — loaded nightly. The timeline shows status changes, not every procedural action.
Money — Senate Lobbying Disclosure Act filings whose specific-issue field names this bill for quarters ending Jun 2026 to Jun 2026. A filing's amount is reported whole beside the median number of bills a filing names; it is never divided across them. PAC receipts are FEC-reported contributions to the sponsor's candidate committee in the 2026 cycle.
As of — lobbying records through Jul 20, 2026 · page rendered 2026-09-23.
- H.R. 9661 on Congress.gov
- Actions and status history
- Cosponsors (2)
- Bill text the analysis read
- Pharmaceutical Research and Manufacturers of America — LDA filing, 2026 Q2
- Blood Cancer United (fka the Leukemia & Lymphoma Society) — LDA filing, 2026 Q2
- American Society of Health-system Pharmacists — LDA filing, 2026 Q2
- Nicholas Langworthy — FEC candidate receipts, 2026 cycle
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