Sec. 503. Clarifications to exclusivity provisions for first interchangeable biosimilar biological products
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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 licensure as an interchangeable biological product effective with respect to ; by striking relying on and inserting 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.
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Sec. 503
Clarifications to exclusivity provisions for first interchangeable biosimilar biological products
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