Shown verbatim: the complete text as captured from the official PDF posted by the Tennessee General Assembly, fetched 2026-09-25. Page and line markers are part of the official record; nothing is edited or removed. This is the chaptered version. The official bill page.
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PUBLIC CHAPTER NO. 206
HOUSE BILL NO. 1198
By Representatives Kumar, Terry
Substituted for: Senate Bill No. 436
By Senator Reeves
AN ACT to amend Tennessee Code Annotated, Title 4; Title 53; Title 56; Title 68 and
Title 71, relative to biosimilar medicine.
WHEREAS, the legislature finds that increasing access to biosimilar medicines has the
potential to significantly reduce prescription drug costs; and
WHEREAS, biosimilar medicines are approved according to the same federal Food and
Drug Administration (FDA) standards of pharmaceutical quality, safety, and efficacy as the
FDA's reference medicines; and
WHEREAS, it is the intent of the legislature to eliminate barriers impeding access to
biosimilar medicines and the savings biosimilar medicines can provide; now, therefore,
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
SECTION 1. Tennessee Code Annotated, Section 4-3-1013(e), is amended by adding
the language "or biosimilars, as that term is defined in § 56-7-3501" at the end of the
subsection.
SECTION 2. Tennessee Code Annotated, Section 56-7-3501, is amended by adding the
following as a new subdivision:
( ) "Biosimilar" means a biological product that is licensed under 42 U.S.C. §
262(k) and that is not listed as "discontinued" in the federal food and drug
administration's database of licensed biological products, also known as the "Purple
Book";
SECTION 3. Tennessee Code Annotated, Section 56-7-3502(f)(1), is amended by
deleting the subdivision and substituting:
(1) A health carrier, health benefit plan, or utilization review organization from
requiring a patient to try an AB-rated generic equivalent product, interchangeable
biological product, or biosimilar product prior to providing coverage for the equivalent
branded prescription drug;
SECTION 4. Tennessee Code Annotated, Section 71-5-103, is amended by adding the
following as a new subdivision:
( ) "Biosimilar" means a biological product that is licensed under 42 U.S.C. §
262(k) and that is not listed as "discontinued" in the federal food and drug
administration's database of licensed biological products, also known as the "Purple
Book";
SECTION 5. Tennessee Code Annotated, Section 71-5-198(c), is amended by adding
the language "or biosimilars" at the end of the subsection.
SECTION 6. Tennessee Code Annotated, Section 71-5-2404(a), is amended by deleting
the language "including, but not limited to, efficacy, the use of generic drugs and therapeutic
equivalent drugs, and cost information related to each drug" and substituting "including efficacy;
the use of generic drugs, biosimilars, as that term is defined in § 71-5-103, and therapeutic
equivalent drugs; and cost information related to each drug".
HB1198
SECTION 7. This act takes effect upon becoming a law, the public welfare requiring it.
2
HOUSE BILL NO. 1198
PASSED: March 31, 2025
CAMERON SEXTON, SPEAKER
HOUSE OF REPRESENTATIVES
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SPEAKER OF THE SENATE
APPROVED this \\\l.. day of t\pri\ 2025
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