Protecting Access to Biosimilars Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 2011 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 biologics license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009. IN THE HOUSE OF REPRESENTATIVES APRIL 1, 2019 Ms. DEGETTE (for herself, Mr. REED, Ms. SCHRIER, and Mr. GUTHRIE) in- troduced the following bill; which was referred to the Committee on En- ergy and Commerce 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 biologics license pursuant to sec- tion 7002 of the Biologics Price Competition and Innova- tion 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 23:20 Apr 12, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2011.IH H2011 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 2011 IH 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) APPLICABILITY OF 16 ANTIEVERGREENING PROVISIONS.—Sub- 17 paragraph (C) shall apply to any reference 18 product, without regard to whether— 19 ‘‘(I) such product was first li- 20 censed under subsection (a); or 21 ‘‘(II) the approved application for 22 such product was deemed to be a li- 23 cense for a biological product as de- 24 scribed in clause (i).’’. 25 Æ VerDate Sep 11 2014 23:20 Apr 12, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\H2011.IH H2011 pamtmann on DSKBFK8HB2PROD with BILLS