,,ii #aahth ,,congress #b;d ,session ,s4 #edei ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #i1 #bjbd,mrs4 ,blackburn introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xi of the ,social ,security ,act to alter when biosimilar biological products are eligible for price negotiations under the ,medicare program4 #a4 ,short title ,this ,act may be cited as the ,biosimilars ,access and ,affordability ,act4 #b4 ,change of when biosimilars are eligible for price negotiations 7a7 ,in general ,section #aaib of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;f-#a7 is amended-- 7#a7 in subsection 7c7-- 7,a7 in paragraph 7#a71 in the matter before subparagraph 7,a71 by striking beginning before the first year that begins at least #i months after the date on which and inserting during the price applicability period1 except that a drug shall no longer be a selected drug for a particular year if1 before the first day of such year12 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7b71 by inserting or after the end of such negotiation period but before the first day of the initial price applicability year after such initial price applicability year2 and 7ii7 in the flush matter following subparagraph 7,b71 by inserting or any future publication of the maximum fair price under section #aaie or any application of such price after such negotiation period2 7#b7 in subsection 7f7-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,a7-- 7,i7 by striking an extended monopoly drug 7as defined in section #aaid7;c77#d72 and 7,,ii7 by striking before the date and inserting on or before ,december #ca of the year2 7ii7 in subparagraph 7,b7-- 7,i7 in the heading1 by striking ,request required and inserting ,procedures2 7,,ii7 by redesignating clauses 7i7 and 7ii7 as clauses 7ii7 and 7iii7 respectively2 7,,iii7 by inserting before clause 7ii7 7as so redesignated7 the following3 7i7 ,automatic delay ,the ,secretary shall apply1 with respect to a biological product described in subparagraph 7,a71 the rules described in subparagraph 7,a7 of paragraph 7#b7 7subject to subparagraphs 7,b7 and 7,c7 of such paragraph7 if1 prior to the selected drug publication date for the list published under subsection 7a7 with respect to the initial price applicability year for which the biological product may have been included as a selected drug on such list but for paragraph 7#b77;,a71 the manufacturer of a biosimilar biological product for which such biological product will be the reference product has publicly disclosed in a press release or other communication1 or the ,secretary determines from information from any other source-- 7,i7 that such manufacturer's application for licensure under section #cea7k7 of the ,public ,health ,service ,act for the biosimilar biological product was accepted for review or approved by the ,food and ,drug ,administration2 7,,ii7 that such manufacturer's clinical study of the biosimilar biological product as described in section #cea7k77#b77;,a77i77,i77cc7 of the ,public ,health ,service ,act was initiated and remains ongoing2 or 7,,iii7 such manufacturer expects that the biosimilar biological product will be marketed on or before ,december #ca of the year that is #b years after the selected drug publication date with respect to such initial price applicability year4 2 7,,iv7 in clause 7ii7 7as so redesignated7-- 7aa7 by striking subclause 7,,ii72 7bb7 by striking ,in general and all that follows through unless and inserting ,delay upon request4-- ,the ,secretary shall provide for a delay under paragraph 7#b77;,a7 if2 and 7cc7 by striking subparagraph 7#b77;,a7 or2 and inserting paragraph 7#b77;,a71 provided that a determination of high likelihood is made under paragraph 7#c742 and 7,v7 in clause 7iii7 7as so redesignated7-- 7aa7 in the heading1 by inserting for a delay upon request after documents2 7bb7 in subclause 7,i71 in the matter before item 7aa71 by striking clause 7i7 and inserting clause 7ii72 and 7cc7 in subclause 7,,iii77bb71 by striking year 7or the #b years1 as applicable7 and inserting applicable period2 and 7iii7 in subparagraph 7,c77i71 by striking paragraph 7#b77;,d77iv7 and inserting paragraph 7#b77;,c77iii72 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a7-- 7,i7 in the heading1 by striking #a year and inserting #b years2 7,,ii7 by inserting or paragraph 7#a77;,b77i7 applies after under paragraph 7#c72 and 7,,iii7 by striking #a year and inserting #b years2 7ii7 by striking subparagraph 7,b7 and inserting the following3 7,b7 ,if not licensed and marketed during the delay ,if1 during the time period between the selected drug publication date on which the biological product would have been included on the list as a selected drug pursuant to subsection 7a7 but for subparagraph 7,a71 and the selected drug publication date with respect to the initial price applicability year that is #b years after the initial price applicability year for which such biological product would have been included as a selected drug on such list1 the ,secretary determines that the biosimilar biological product for which the manufacturer submitted the request under paragraph 7#a77;,b77ii7 7and for which the ,secretary previously made a high likelihood determination under paragraph 7#c77 has not been licensed and marketed under section #cea7k7 of the ,public ,health ,service ,act-- 7i7 the ,secretary shall include the biological product as a selected drug on the list published under subsection 7a7 with respect to the initial price applicability year that is #b years after the initial price applicability year for which such biological product would have been included as a selected drug on such list but for subparagraph 7,a72 and 7ii7 if such biosimilar biological product has not been licensed and marketed under section #cea7k7 of the ,public ,health ,service ,act on or before ,december #ca of the year that is #b years after the selected drug publication date on which the biological product would have been included on the list as a selected drug pursuant to subsection 7a7 but for subparagraph 7,a71 the manufacturer of such biological product shall pay a rebate under paragraph 7#d7 with respect to the years for which such manufacturer would have provided access to a maximum fair price for such biological product but for subparagraph 7,a74 2 7iii7 by striking subparagraph 7,c72 7iv7 by redesignating subparagraph 7,d7 as subparagraph 7,c72 and 7v7 in subparagraph 7,c7 7as so redesignated7-- 7,i7 by striking clause 7ii72 7,,ii7 by redesignating clauses 7iii7 and 7iv7 as clauses 7ii7 and 7iii71 respectively2 7,,iii7 in clause 7ii7 7as so redesignated7-- 7aa7 in the heading1 by striking #a year and inserting #b years2 and 7bb7 by striking #a year has and inserting #b years have2 and 7,,iv7 in clause 7iii77,,ii7 7as so redesignated71 by striking paragraph 7#a77;,b77ii77,i77bb7 and inserting paragraph 7#a77;,b77iii77,i77bb72 7,c7 by striking paragraph 7#c7 and inserting the following3 7#c7 ,high likelihood ,for purposes of this subsection1 there is a high likelihood described in paragraph 7#a7 or paragraph 7#b71 as applicable1 if the ,secretary finds that information from items described in subclauses 7,i77bb7 and 7,,iii7 of paragraph 7#a77;,b77iii7 submitted to the ,secretary by the manufacturer requesting a delay under such paragraph or information submitted to the ,secretary by any other party or otherwise available to the ,secretary from any other source provides clear and convincing evidence that such biosimilar biological product will1 within the time period specified under paragraph 7#a77;,a7 be marketed4 2 and 7,d7 in paragraph 7#d7-- 7i7 in subparagraph 7,a7-- 7,i7 by striking subparagraphs 7,b77ii77,,ii7 and 7,c77ii7 of paragraph 7#b7 and inserting paragraph 7#b77;,b77ii72 and 7,,ii7 by inserting not earlier than ,january #a of the year that is #c years after the selected drug publication date of the list on which the biological product would have been included as a selected drug but for a delay under paragraph 7#b77;,a7 after at such time2 and 7ii7 in subparagraph 7,b7-- 7,i7 in clause 7i71 by striking subclause 7,i7 and inserting the following3 7,i7 #ge percent of the amount by which the average manufacturer price1 as reported by the manufacturer of such covered part ,d drug under section #aibg 7or1 if not reported by such manufacturer under section #aibg1 as reported by such manufacturer to the ,secretary pursuant to the agreement under section #aaic7;a77 for such biological product1 with respect to each of the calendar quarters of the price applicability period that would have applied but for this subsection2 exceeds-- 7aa7 for the initial price applicability year that would have applied but for a delay under paragraph 7#b77;,a71 the maximum fair price negotiated under section #aaid for such biological product under such agreement2 or 7bb7 for the second year of such delay and the remaining period of such delay ending on ,december #ca of the year that is #b years after the selected drug publication date of the list on which the biological product would have been included as a selected drug but for a delay under paragraph 7#b77;,a71 such maximum fair price1 increased as described in section #aaie7;b77#a77;,a72 and 2 and 7,,ii7 in clause 7ii71 by striking subclause 7,i7 and inserting the following3 7,i7 #hj percent of the amount by which the payment amount for such biological product under section #ahdg;,a7b71 with respect to each of the calendar quarters of the price applicability period that would have applied but for this subsection2 exceeds-- 7aa7 for the initial price applicability year that would have applied but for a delay under paragraph 7#b77;,a71 the maximum fair price negotiated under section #aaid for such biological product under such agreement2 or 7bb7 for the second year of such delay and the remaining period of such delay ending on ,december #ca of the year that is #b years after the selected drug publication date of the list on which the biological product would have been included as a selected drug but for a delay under paragraph 7#b77;,a71 such maximum fair price1 increased as described in section #aaie7;b77#a77;,a72 and 2 and 7#c7 by adding at the end the following new subsection3 7g7 ,definition of market ,in this section1 the term market means to introduce or deliver a drug or biological product 7including a biosimilar biological product7 for introduction into interstate commerce4 4 7b7 ,conforming and technical amendments ,such ,act is amended-- 7#a7 in section #aaib7;b77#c7 7#db ,u4,s4,c4 #acbj;f-#a7;b77#c771 by striking subparagraphs 7,b77ii77,i7 and 7,c77i7 of subsection 7f77#b7 and inserting subsection 7f77#b77;,b77ii72 and 7#b7 in section #aaih7b7 7#db ,u4,s4,c4 #acbj;f-#g7b771 by striking #aaib7;f71 and inserting #aaib7;f74 7c7 ,effective date ,the amendments made by this section shall apply with respect to initial price applicability years beginning with initial price applicability year #bjbg4