Section 1 Short title
This Act may be cited as the “Interchangeable Biologics Clarity Act”.
Interchangeable Biologics Clarity Act
A BILL
To provide for a period of exclusivity for first interchangeable biological products.
Sec. 2 Clarifications to exclusivity provisions for first interchangeable biosimilar biological products
Section 351(k)(6) of the Public Health Service Act (42 U.S.C. 262(k)(6)) is amended—
in the matter preceding subparagraph (A)—
by striking “Upon review of” and inserting “The Secretary shall not make approval effective of”;
by striking “relying on” and inserting “for an interchangeable biological product that relies on”; and
by striking “the Secretary shall not make a determination under paragraph (4) that the second or subsequent biological product is interchangeable for any condition of use”; and
in the flush text that follows subparagraph (C), by striking the period and inserting “, and the term first interchangeable biosimilar biological product means any interchangeable biosimilar biological product that is approved on the first day on which such a product is approved as interchangeable with the reference product.”.