Protecting Access to Biosimilars Act of 2019

II 116TH CONGRESS 1ST SESSION S. 1140 To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innova- tion Act of 2009. IN THE SENATE OF THE UNITED STATES APRIL 11, 2019 Ms. SMITH (for herself and Mr. CASSIDY) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relat- ing to exclusivity for reference products) of certain prod- ucts deemed to have a biological product license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Protecting Access to 4 Biosimilars Act of 2019’’. 5 VerDate Sep 11 2014 00:36 Apr 18, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1140.IS S1140 kjohnson on DSK79L0C42 with BILLS 2 •S 1140 IS SEC. 2. TREATMENT OF BIOLOGICAL PRODUCTS DEEMED 1 LICENSED. 2 Section 351(k)(7) of the Public Health Service Act 3 (42 U.S.C. 262(k)(7)) is amended by adding at the end 4 the following: 5 ‘‘(D) DEEMED LICENSES.— 6 ‘‘(i) NO ADDITIONAL EXCLUSIVITY 7 THROUGH DEEMING.—An approved appli- 8 cation that is deemed to be a license for a 9 biological product under this section pursu- 10 ant to section 7002(e)(4) of the Biologics 11 Price Competition and Innovation Act of 12 2009 shall not be treated as having been 13 first licensed under subsection (a) for pur- 14 poses of subparagraphs (A) and (B). 15 ‘‘(ii) LIMITATION ON EXCLUSIVITY AP- 16 PLIES TO ANY REFERENCE PRODUCT.— 17 Subparagraph (C) shall apply to any ref- 18 erence product, without regard to wheth- 19 er— 20 ‘‘(I) such product was first li- 21 censed under subsection (a); or 22 ‘‘(II) the approved application for 23 such product was deemed to be a li- 24 VerDate Sep 11 2014 00:36 Apr 18, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1140.IS S1140 kjohnson on DSK79L0C42 with BILLS 3 •S 1140 IS cense for a biological product as de- 1 scribed in clause (i).’’. 2 Æ VerDate Sep 11 2014 00:36 Apr 18, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\S1140.IS S1140 kjohnson on DSK79L0C42 with BILLS