S2305-118

Introduced

To improve the requirements for making a determination of interchangeability of a biological product and its reference product.

118th Congress Introduced Jul 13, 2023

Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.

Summary

What This Bill Does

This bill, To improve the requirements for making a determination of interchangeability of a biological product and its reference product., changes federal law or congressional policy affecting health care providers and patients. The main policy domain is Healthcare, Government Operations, Education.

Who Benefits and How

health care providers and patients may benefit from new authority, funding, eligibility, regulatory clarity, or reduced risk created by the bill.

Who Bears the Burden and How

federal implementing agencies, health care providers and patients may take on implementation duties, reporting obligations, compliance costs, or oversight responsibilities.

Key Provisions

  • Section id86FA91A307794378AEF4A870B9F6AFD6: 1. Short title This Act may be cited as the Biosimilar Red Tape Elimination Act.
  • Section id5235B2B63FB24498A4EC14A952A92156: 2. Biosimilar biological products Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) is amended— in the subsection heading, by striking or...

Evidence Chain:

This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.

At a Glance

What This Bill Does

This bill, To improve the requirements for making a determination of interchangeability of a biological product and its reference product., changes federal law or congressional policy affecting health care providers and patients.

Key Policy Areas

Healthcare, Government Operations, Education

Primary Purpose

This bill, To improve the requirements for making a determination of interchangeability of a biological product and its reference product., changes federal law or congressional policy affecting health care providers and patients.

Policy Domains

Healthcare Government Operations Education

Whole bill

Identified Gains
  • health care providers and patients
Model: codex-gpt-5 | Version: bill_summary_v2 | Source: is
health care providers and patients:
Identified Costs
  • federal implementing agencies
  • health care providers and patients
Model: codex-gpt-5 | Version: bill_summary_v2 | Source: is
federal implementing agencies:
health care providers and patients:

Legislative Progress

Introduced
Introduced Committee Passed
Jul 13, 2023

Mr. Lee (for himself, Mr. Luján, Mr. Braun, and Mr. …

Impact analysis is available but no clear stakeholder effects identified. View clause-level analysis →

Bill Structure & Actor Mappings

Who is "The Secretary" in each section?

Domains
Healthcare Government Operations Education
Actor Mappings
"the_secretary"
→ The Secretary identified in the operative section

We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.

Learn more about our methodology