CLARIFICATIONS TO EXCLUSIVITY PROVISIONS FOR FIRST INTERCHANGEABLE BIOSIMILAR BIOLOGICAL PRODUCTS.

SEC. 3206. 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—(1) in the matter preceding subparagraph (A)—(A) by striking “Upon review of” and inserting “The Secretary shall not make approval as an interchangeable biological product effective with respect to”; (B) by striking “relying on” and inserting “that relies on”; and (C) 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 (2) in the flush text that follows subparagraph (C)(ii), by striking “taken.” and inserting “taken, 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.”.