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# House Bill to Make Biosimilars Fast Track Law
- URL: https://www.fdaweb.com/house-bill-to-make-biosimilars-fast-track-law/
- Published: 2019-04-01T12:00:00.000Z
- Updated: 2026-09-15T01:17:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143748

Legislation introduced by Reps. **Diana DeGette** (D-CO) and **Tom Reed** (R-NY), who serve as the co-chairs of the Congressional Diabetes Caucus, would make permanent a new FDA policy that was put in place in December to help speed up the time it takes for biosimilars to get approved. “We know that one of the best ways to reduce the cost of insulin is to increase competition,” DeGette said in a [release](https://degette.house.gov/media-center/press-releases/degette-introduces-bill-aimed-at-bringing-down-cost-of-insulin?ref=fdaweb.com). “Despite insulin being available for nearly 100 years now, there are still only three companies that manufacture the drug here in the U.S. and only one generic version of the drug is available to consumers.”

DeGette and Reed sent a letter in 2017 to FDA commissioner **Scott Gottlieb** urging him to create a new regulatory pathway that would help speed up the approval process for biosimilars like insulin by allowing drug makers to piggyback on some of the early clinical trials that the brand-name version of the drug used to get approved. FDA issued new guidelines 12/11/2018 that created a new fast-track approval process for biosimilars as the two lawmakers had suggested.

The new bill would set those new FDA guidelines into law to prevent any future administrations from revoking them, the lawmakers say.