Section 1 Short title
This Act may be cited as the “Biosimilar Red Tape Elimination Act”.
Biosimilar Red Tape Elimination Act
A BILL
To improve the requirements for making a determination of interchangeability of a biological product and its reference product.
Sec. 2 Biosimilar biological products
Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) is amended—
in paragraph (2)(A)(i)(I)(bb), by striking “; and” and inserting “; or”; and
in paragraph (4)—
at the end of subparagraph (A)(ii), by striking “; and” and inserting a period;
by striking “sufficient to show” and all that follows through “(A) the biological product—” and inserting “sufficient to show that the biological product—”;
by striking “Upon review of an” and inserting the following:
“(A) In general—Upon review of an”
by amending subparagraph (B) to read as follows:
“(B) Certain studies not required—The Secretary may not require, for a determination of interchangeability described in subparagraph (A), that a biological product undergo studies that assess the risks of alternating or switching between use of the biological product and the reference product.”