Biosimilar Red Tape Elimination Act

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 5526 Introduced in House (IH)] <DOC> 119th CONGRESS 1st Session H. R. 5526 To improve the requirements for making a determination of interchangeability of a biological product and its reference product. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES September 19, 2025 Mr. Pfluger (for himself and Mr. Landsman) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL To improve the requirements for making a determination of interchangeability of a biological product and its reference product. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Biosimilar Red Tape Elimination Act''. SEC. 2. BIOSIMILAR BIOLOGICAL PRODUCTS. (a) In General.--Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) is amended-- (1) in the subsection heading, by striking ``or Interchangeable''; (2) in paragraph (2)-- (A) by striking subparagraph (B); (B) by redesignating clauses (ii) and (iii) of subparagraph (A) as subparagraphs (B) and (C), respectively, and adjusting the margins accordingly; (C) in subparagraph (A)-- (i) in clause (i), by redesignating subclauses (I) through (V) as clauses (i) through (v), respectively, and adjusting the margins accordingly; (ii) in clause (i), as so redesignated by clause (i) of this subparagraph, by redesignating items (aa) through (cc) as subclauses (I) through (III), respectively, and adjusting the margins accordingly; (iii) in subclause (II) of clause (i), as so redesignated by clause (ii) of this subparagraph, by striking ``item (aa) or (cc)'' and inserting ``subclause (I) or (III)''; and (iv) by striking ``(a) in general'' and all that follows through ``An application sub