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# Bipartisan Bill on Interchangeable Biologics
- URL: https://www.fdaweb.com/bipartisan-bill-on-interchangeable-biologics/
- Published: 2023-03-28T12:00:00.000Z
- Updated: 2026-09-14T18:22:17.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154085

U.S. Representatives **Mariannette Miller-Meeks** (R-IA), **Greg Murphy** (R-NC), **Nanette Barragán** (D-CA), and **Annie Kuster** (D-NH) have introduced the Biologics Competition Act, a bipartisan [bill](https://millermeeks.house.gov/sites/evo-subsites/millermeeks.house.gov/files/evo-media-document/biologics-competition-act.pdf?ref=fdaweb.com) that would order HHS to evaluate the process by which interchangeable biological products are approved and designated for substitution purposes in pharmacies. Specifically, the bill seeks an HHS study to “evaluate the extent to which the substitution of inter-changeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs.”

The lawmakers say they are concerned about pharmacy confusion because the generic drug approval process is different from that of biosimilar products. “When a generic drug is approved it is assigned a Therapeutic Equivalence (TE) rating, but biological products are instead designated as ‘interchangeable’ which creates uncertainty among pharmacists,” they say. “Because interchangeable products are new to the industry, there have been very few reports done to examine the efficiency of their approval process.”

The HHS evaluation is intended to harmonize the approach for communicating the substitutability of interchangeable biological products with the approach for communicating therapeutic equivalence ratings assigned to drugs, with the goal of minimizing any impediments to the substitution of interchangeable biological products, according to the bill.