S. 1414 (Reported-in-Senate)

To amend the Public Health Service Act to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SEC. 2. 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.

SECTION 1. Short title.

This Act may be cited as the “Expedited Access to Biosimilars Act”.

SEC. 2. Data 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)—

(i) by striking “or (cc)” and inserting “, (cc), or (dd)”; and

(ii) by striking “and” at the end; and

(B) by striking item (cc) and inserting the following

“(cc) an assessment of pharmacokinetics and immunogenicity (which may rely on, or consist of, a clinical pharmacokinetics study or studies described in item (aa) or (dd)), as appropriate; and

“(dd) a clinical study or studies, if required by the Secretary pursuant to clause (ii)(II), to support a demonstration that there is no clinically meaningful difference between the biological product and the reference product in terms of safety, purity, and potency of such product;”; and

(2) in clause (ii)—

(A) in the clause heading, by striking “Determination” and inserting “Determinations”;

(B) by striking “The Secretary may” and inserting the following:

“(I) IN GENERAL.—The Secretary may”; and

(C) by adding at the end the following:

“(II) PROCEDURE FOR CERTAIN STUDIES.—

“(aa) IN GENERAL.—For an application for licensure of a biosimilar biological product submitted under this subsection, the Secretary may require a clinical study that includes an assessment of pharmacodynamics or efficacy, as described in clause (i)(I)(dd), only if the Secretary provides a written determination, as described in item (bb) or (cc), to the sponsor of the biosimilar biological product that such assessments or studies are necessary, in combination with other information required pursuant to clause (i)(I), to demonstrate biosimilarity.

“(bb) WRITTEN DETERMINATION.—The Secretary shall—

“(AA) when the Secretary issues meeting minutes of a biosimilar biological product development meeting (as such term is defined in section 744G(5) of the Federal Food, Drug, and Cosmetic Act), provide a written determination described in item (aa), or provide written notice to the sponsor that describes why such a determination can not be made at such time; and

“(BB) if the Secretary is unable to make a written determination described in item (aa) at the time described in subitem (AA), provide such determination not later than 60 days after the date of submission of an application for licensure under this section.

“(cc) AMENDMENT TO A DETERMINATION.—A written determination under this subclause shall not be amended to require a clinical study or studies described in clause (i)(I)(dd) after the date on which such a determination is made, except—

“(AA) by written agreement with the sponsor; or

“(BB) in the case that the Secretary determines there is a scientific justification to amend the determination, provides a detailed written justification to the sponsor as soon as practicable, and, upon the request of the sponsor, holds a biosimilar biological product development meeting (as such term is defined in section 744G(5) of the Federal Food, Drug, and Cosmetic Act) to discuss the amendment.”.

(b) Streamlining biosimilar reviews.—Section 351(k)(5) of the Public Health Service Act (42 U.S.C. 262(k)(5)) is amended—

(1) by striking subparagraph (B); and

(2) by redesignating subparagraph (C) as subparagraph (B).

(c) Applicability.—The amendments made by subsections (a) and (b) 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.