Expediting competitive biosimilar competition

(a) In general Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) is amended by adding at the end the following: (10) Expediting competitive biosimilar competition (A) In general The Secretary may, at the request of the sponsor of an application under this subsection for a biosimilar biological product that is designated as a competitive biosimilar therapy pursuant to subsection (b), expedite the development and review of such application under this subsection. (B) Designation process (i) Request The sponsor of an application under this subsection may request the Secretary to designate the drug as a competitive biosimilar therapy. A request for such designation may be made concurrently with, or at any time prior to, the submission of a biosimilar biological product license application under this subsection. (ii) Criteria A biological product is eligible for designation as a competitive biosimilar therapy under this paragraph if the Secretary determines that there is inadequate biosimilar competition. (iii) Designation Not later than 60 calendar days after the receipt of a request under clause (i), the Secretary may— (I) determine whether the biosimilar biological product that is the subject of the request meets the criteria described in clause (ii); and (II) if the Secretary finds that such product meets such criteria, designate the biosimilar biological product as a competitive biosimilar therapy. (C) Actions In expediting the development and review of an application under subparagraph (A), the Secretary may, as requested by the applicant, take actions including the following: (i) Hold meetings with the sponsor and the review team throughout the development of the biosimilar biological product prior to submission of the application under this subsection. (ii) Provide timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable. (iii) Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review of such application, including with respect to biological product-device combination products and other complex products. (iv) Assign a cross-disciplinary project lead— (I) to facilitate an efficient review of the development program and application, including manufacturing inspections; and (II) to serve as a scientific liaison between the review team and the applicant. (D) Inspections With respect to an application described in subparagraph (A), in the case of an inspection report that finds approval of such biological product is dependent upon remediation of a facility, if the applicant attests that necessary changes have been made to the facility, the Secretary shall expedite reinspection of such facility, including establishing a set timeline to reinspect the facility or make a determination about the response of the applicant and whether to approve the application. (E) Reporting requirement Not later than 1 year after the date of licensure under this subsection with respect to a biosimilar biological product for which the development and review is expedited under this paragraph, the holder of the license of such biosimilar biological product shall report to the Secretary on whether the biosimilar biological product has been marketed in interstate commerce since the date of such licensure. (F) Inadequate biosimilar competition In this paragraph, the term inadequate biosimilar competition means, with respect to a biological product, there are fewer than 3 licensed biological products on the list published under paragraph (9)(A) (not including biological products on the discontinued section of such list) that are biosimilar biological products with the same reference product..