The full text of the Pathway for Biosimilars Act (H.R. 1548) introduced in the House has now been released. The Act is set to amend the Public Health Service Act in order to establish a pathway for the licensure of biosimilar biological products, and for other purposes.
The Act provides for the following:
EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT
The Secretary shall not make a determination under paragraph (4) that a second or subsequent biological product is interchangeable with the same reference product for which a prior biological product has received a determination of interchangeability until 24 months after the later of–
(A) the date of the first commercial marketing of the first biosimilar biological product determined to be interchangeable for that reference product; or
(B) with respect to a product marketed before the date the product is determined to be interchangeable, the date that the product is determined to be interchangeable.
…approval…may not be made until the date that is 12 years after the reference product was first licensed…
EXCLUSIVITY FOR REFERENCE PRODUCT
(A) EFFECTIVE DATE OF BIOSIMILAR APPLICATION LICENSURE- Subject to subparagraph (D) and paragraph (8), approval of an application under this subsection may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a).
(B) FILING PERIOD- An application under this subsection may not be submitted to the Secretary until the later of–
(i) the date of commencement of a proceeding for issuance of guidance pursuant to paragraph (9) with respect to the product class within which the product that is the subject of such application falls; or
(ii) the date that is 4 years after the date on which the reference product was first licensed under subsection (a).
(C) FIRST LICENSURE- For purposes of this paragraph, the date on which the reference product was first licensed under subsection (a) does not include the date of approval of a supplement or of a subsequent application for a new indication, route of administration, dosage form, or strength for the previously licensed reference product.
(D) MEDICALLY SIGNIFICANT NEW INDICATION- If, during the 8-year period following licensure of the reference product, the Secretary approves a supplement to the application for the reference product that seeks approval to market the reference product for a new indication that, if approved, would be a significant improvement, compared to marketed products, in the treatment, diagnosis, or prevention of disease, approval of an application submitted under this subsection may not be made effective by the Secretary until the date that is 14 years after the date on which the reference product was first licensed under subsection (a).
PEDIATRIC STUDIES.
(A) EXCLUSIVITY- If, before or after licensure of the reference product under subsection (a) of this section, the Secretary determines that information relating to the use of such product in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), the applicant or holder of the approved application agrees to the request, such studies are completed using appropriate formulations for each age group for which the study is requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with section 505A(d)(3) of the Federal Food, Drug, and Cosmetic Act–
(i) the period referred to in paragraph (7)(A) of this subsection is deemed to be 12 years and 6 months rather than 12 years; and
(ii) if paragraph (7)(D) of this subsection applies, the period referred to in such paragraph is deemed to be 14 years and 6 months rather than 14 years.
(B) EXCEPTION- The Secretary shall not extend the period referred to in subparagraph (A)(i) or (A)(ii) of this paragraph if the determination under section 505A(d)(3) of the Federal Food, Drug, and Cosmetic Act is made later than 9 months prior to the expiration of such period.
(C) APPLICATION OF CERTAIN PROVISIONS- The provisions of subsections (a), (d), (e), (f), (h), (j), (k), and (l) of section 505A of the Federal Food, Drug, and Cosmetic Act shall apply with respect to the extension of a period under subparagraph (A) of this paragraph to the same extent and in the same manner as such provisions apply with respect to the extension of a period under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act.
