Assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy in clinical studies required for licensure of biological products as biosimilar

(a) In general Section 351(k)(2)(A) of the Public Health Service Act (42 U.S.C. 262(k)(2)(A)) is amended— (1) in clause (i)(I)— (A) in item (bb), by striking and at the end; and (B) by striking item (cc) and inserting the following (cc) a clinical study or studies assessing pharmacokinetics that are sufficient to demonstrate safety, purity, and potency; and (dd) subject to clause (iv), a clinical study or studies that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product;; and (2) by adding at the end the following: (iv) Clinical studies (I) In general Subject to subclause (II), the Secretary may determine, in the Secretary's discretion, that a clinical study required under clause (i)(I)(dd) shall include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy. (II) Requirement The Secretary may only require the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy pursuant to a determination under subclause (I) if the Secretary provides to the applicant notice of the requirement, including a written justification of the basis for such determination, not later than the earliest date on which the applicant may file the application under this subsection.. (b) Applicability The amendments made by subsection (a) shall apply with respect to an application submitted under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) on or after the date of enactment of this Act.