FDA gets new rules for approving cheaper copy drugs faster

What it does

The bill changes how the FDA approves biosimilar drugs. These are cheaper copies of expensive biologic medicines. The FDA can skip some expensive tests in certain cases. The FDA must write down why it skips tests. It must do this within 60 days of getting an application. The FDA cannot add new test rules after 60 days. It can only add rules if the manufacturer agrees or science requires it.

Who it affects

Patients who take expensive biologic drugs could pay less. Cheaper copies could reach the market faster. Drug makers that produce biosimilars could get faster approval.

One thing to notice

The bill lets the FDA skip some safety tests for cheaper copy drugs. The FDA must explain in writing why it skips those tests.

From the analysis of the bill text, linked under Primary records below.

Where it stands

2 cosponsors: 1 Democrats, 1 Republicans.

• Apr 10, 2025 — Introduced · Congress.gov: “Introduced in Senate”
• Apr 10, 2025 — Referred to Senate Committee on Health, Education, Labor, and Pensions · Congress.gov: “Read twice and referred to the Committee on Health, Education, Labor, and Pensions”
• Jul 22, 2026 — Reported out of committee · Congress.gov: “Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature…”

Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.

Money around this bill

12 groups reported lobbying about this bill. They filed 15 reports from Dec 2025 to Jun 2026.

Those reports show $27,372,990 in lobbying spending. Each report lists about 26 bills. So that money was not all for this bill.

More groups named this bill than 93% of bills with any report.

Rand Paul, who sponsored the bill, received $91,145 from PACs for the 2026 election.

• Pharmaceutical Research and Manufacturers of America — $15,770,000 in 2 reports
• Pharmaceutical Care Management Association — $3,282,990 in 1 report
• Amgen Inc — $2,440,000 in 1 report
• Biotechnology Innovation Organization — $2,360,000 in 1 report
• Gsk (fka Glaxosmithkline Inc.) — $890,000 in 1 report

Lobbying is legal. These reports show who lobbied about this bill, not what changed.

Words to know

• biosimilar — A cheaper copy of an expensive biologic medicine that works the same way
• biologic — A medicine made from living cells or organisms, not from chemicals
• FDA — The Food and Drug Administration, the U.S. agency that approves medicines
• 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.