,,ii  #aah? ,,congress  #b;d ,session   
,s4 #edei  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,decemb] #i1 #bjbd,mrs4
 ,blackburn introduc$ ! foll[+ bill2 :i*
 0 read twice & ref]r$ to ! ,committee  
on ,f9ance  ,a ,,bill  ,to am5d title   
,,xi ( ! ,social ,security ,act to alt] 
:5 biosimil> biological products are    
eligible = price negotiations "u !      
,m$ic>e program4  #a4 ,%ort title ,?is  
,act may be cit$ z ! ,biosimil>s ,access
 & ,af=dability ,act4  #b4 ,*ange ( :5  
biosimil>s are eligible = price         
negotiations  7a7 ,9 g5]al ,section     
#aaib ( ! ,social ,security ,act 7#db   
,u4,s4,c4 #acbj;f-#a7 is am5d$-- 7#a7 9 
subsection 7c7-- 7,a7 9 p>agraph 7#a71 9
 ! matt] be=e subp>agraph 7,a71 by /rik+
 beg9n+ be=e ! fir/ ye> t beg9s at lea/ 
#i mon?s aft] ! date on :i* & ins]t+    
dur+ ! price applicability p]iod1 except
 t a drug %all no long] be a select$    
drug = a p>ticul> ye> if1 be=e ! fir/   
day ( su* ye>12  7,b7 9 p>agraph 7#b7-- 
7i7 9 subp>agraph 7b71 by ins]t+ or aft]

 ! end ( su* negotiation p]iod b be=e ! 
fir/ day ( ! initial price applicability
 ye> aft] su* initial price             
applicability ye>2 &  7ii7 9 ! flu%     
matt] foll[+ subp>agraph 7,b71 by ins]t+
 or any future publication ( ! maximum  
fair price "u section #aaie or any      
application ( su* price aft] su*        
negotiation p]iod2  7#b7 9 subsection   
7f7-- 7,a7 9 p>agraph 7#a7-- 7i7 9      
subp>agraph 7,a7-- 7,i7 by /rik+ an     
ext5d$ monopoly drug 7z def9$ 9 section 
#aaid7;c77#d72 &  7,,ii7 by /rik+ be=e !
 date & ins]t+ on or be=e ,decemb] #ca (
 ! ye>2  7ii7 9 subp>agraph 7,b7-- 7,i7 
9 ! head+1 by /rik+ ,reque/ requir$ &   
ins]t+ ,proc$ures2  7,,ii7 by r$esignat+
 clauses 7i7 & 7ii7 z clauses 7ii7 &    
7iii7 respectively2  7,,iii7 by ins]t+  
be=e clause 7ii7 7z s r$esignat$7 !     
foll[+3  7i7 ,automatic delay ,!        
,secret>y %all apply1 ) respect to a    
biological product describ$ 9           
subp>agraph 7,a71 ! rules describ$ 9    
subp>agraph 7,a7 ( p>agraph 7#b7        

7subject to subp>agraphs 7,b7 & 7,c7 (  
su* p>agraph7 if1 prior to ! select$    
drug publication date = ! li/ publi%$ "u
 subsection 7a7 ) respect to ! initial  
price applicability ye> = :i* !         
biological product may h be5 includ$ z a
 select$ drug on su* li/ b = p>agraph   
7#b77;,a71 ! manufactur] ( a biosimil>  
biological product = :i* su* biological 
product w be ! ref]5ce product has      
publicly disclos$ 9 a press release or  
o!r communication1 or ! ,secret>y       
det]m9es f in=mation f any o!r s\rce--  
7,i7 t su* manufactur]'s application =  
lic5sure "u section #cea7k7 ( ! ,public 
,heal? ,s]vice ,act = ! biosimil>       
biological product 0 accept$ = review or
 approv$ by ! ,food & ,drug             
,adm9i/ration2  7,,ii7 t su*            
manufactur]'s cl9ical /udy ( ! biosimil>
 biological product z describ$ 9 section
 #cea7k77#b77;,a77i77,i77cc7 ( ! ,public
 ,heal? ,s]vice ,act 0 initiat$ & rema9s
 ongo+2 or  7,,iii7 su* manufactur]     
expects t ! biosimil> biological product

 w be m>ket$ on or be=e ,decemb] #ca ( !
 ye> t is #b ye>s aft] ! select$ drug   
publication date ) respect to su*       
initial price applicability ye>4  2     
7,,iv7 9 clause 7ii7 7z s r$esignat$7-- 
7aa7 by /rik+ subclause 7,,ii72  7bb7 by
 /rik+ ,9 g5]al & all t foll[s ?r\gh    
unless & ins]t+ ,delay ^u reque/4-- ,!  
,secret>y %all provide = a delay "u     
p>agraph 7#b77;,a7 if2 &  7cc7 by /rik+ 
subp>agraph 7#b77;,a7 or2 & ins]t+      
p>agraph 7#b77;,a71 provid$ t a         
det]m9ation ( high likelihood is made "u
 p>agraph 7#c742 &  7,v7 9 clause 7iii7 
7z s r$esignat$7-- 7aa7 9 ! head+1 by   
ins]t+ = a delay ^u reque/ aft]         
docum5ts2  7bb7 9 subclause 7,i71 9 !   
matt] be=e item 7aa71 by /rik+ clause   
7i7 & ins]t+ clause 7ii72 &  7cc7 9     
subclause 7,,iii77bb71 by /rik+ ye> 7or 
! #b ye>s1 z applicable7 & ins]t+       
applicable p]iod2 &  7iii7 9 subp>agraph
 7,c77i71 by /rik+ p>agraph             
7#b77;,d77iv7 & ins]t+ p>agraph         
7#b77;,c77iii72  7,b7 9 p>agraph 7#b7-- 

7i7 9 subp>agraph 7,a7-- 7,i7 9 ! head+1
 by /rik+ #a ye> & ins]t+ #b ye>s2      
7,,ii7 by ins]t+ or p>agraph            
7#a77;,b77i7 applies aft] "u p>agraph   
7#c72 &  7,,iii7 by /rik+ #a ye> &      
ins]t+ #b ye>s2  7ii7 by /rik+          
subp>agraph 7,b7 & ins]t+ ! foll[+3     
7,b7 ,if n lic5s$ & m>ket$ dur+ ! delay 
,if1 dur+ ! "t p]iod betwe5 ! select$   
drug publication date on :i* !          
biological product w\ld h be5 includ$ on
 ! li/ z a select$ drug pursuant to     
subsection 7a7 b = subp>agraph 7,a71 & !
 select$ drug publication date ) respect
 to ! initial price applicability ye> t 
is #b ye>s aft] ! initial price         
applicability ye> = :i* su* biological  
product w\ld h be5 includ$ z a select$  
drug on su* li/1 ! ,secret>y det]m9es t 
! biosimil> biological product = :i* !  
manufactur] submitt$ ! reque/ "u        
p>agraph 7#a77;,b77ii7 7& = :i* !       
,secret>y previ\sly made a high         
likelihood det]m9ation "u p>agraph 7#c77
 has n be5 lic5s$ & m>ket$ "u section   

#cea7k7 ( ! ,public ,heal? ,s]vice      
,act-- 7i7 ! ,secret>y %all include !   
biological product z a select$ drug on !
 li/ publi%$ "u subsection 7a7 ) respect
 to ! initial price applicability ye> t 
is #b ye>s aft] ! initial price         
applicability ye> = :i* su* biological  
product w\ld h be5 includ$ z a select$  
drug on su* li/ b = subp>agraph 7,a72 & 
7ii7 if su* biosimil> biological product
 has n be5 lic5s$ & m>ket$ "u section   
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
on or be=e ,decemb] #ca ( ! ye> t is #b 
ye>s aft] ! select$ drug publication    
date on :i* ! biological product w\ld h 
be5 includ$ on ! li/ z a select$ drug   
pursuant to subsection 7a7 b =          
subp>agraph 7,a71 ! manufactur] ( su*   
biological product %all pay a rebate "u 
p>agraph 7#d7 ) respect to ! ye>s = :i* 
su* manufactur] w\ld h provid$ access to
 a maximum fair price = su* biological  
product b = subp>agraph 7,a74  2  7iii7 
by /rik+ subp>agraph 7,c72  7iv7 by     
r$esignat+ subp>agraph 7,d7 z           

subp>agraph 7,c72 &  7v7 9 subp>agraph  
7,c7 7z s r$esignat$7-- 7,i7 by /rik+   
clause 7ii72  7,,ii7 by r$esignat+      
clauses 7iii7 & 7iv7 z clauses 7ii7 &   
7iii71 respectively2  7,,iii7 9 clause  
7ii7 7z s r$esignat$7-- 7aa7 9 ! head+1 
by /rik+ #a ye> & ins]t+ #b ye>s2 &     
7bb7 by /rik+ #a ye> has & ins]t+ #b    
ye>s h2 &  7,,iv7 9 clause 7iii77,,ii7  
7z s r$esignat$71 by /rik+ p>agraph     
7#a77;,b77ii77,i77bb7 & ins]t+ p>agraph 
7#a77;,b77iii77,i77bb72  7,c7 by /rik+  
p>agraph 7#c7 & ins]t+ ! foll[+3  7#c7  
,high likelihood ,= purposes ( ?is      
subsection1 !re is a high likelihood    
describ$ 9 p>agraph 7#a7 or p>agraph    
7#b71 z applicable1 if ! ,secret>y f9ds 
t in=mation f items describ$ 9          
subclauses 7,i77bb7 & 7,,iii7 ( p>agraph
 7#a77;,b77iii7 submitt$ to ! ,secret>y 
by ! manufactur] reque/+ a delay "u su* 
p>agraph or in=mation submitt$ to !     
,secret>y by any o!r p>ty or o!rwise    
available to ! ,secret>y f any o!r s\rce
 provides cle> & conv9c+ evid5ce t su*  

biosimil> biological product w1 )9 ! "t 
p]iod specifi$ "u p>agraph 7#a77;,a7 be 
m>ket$4  2 &  7,d7 9 p>agraph 7#d7-- 7i7
 9 subp>agraph 7,a7-- 7,i7 by /rik+     
subp>agraphs 7,b77ii77,,ii7 & 7,c77ii7 (
 p>agraph 7#b7 & ins]t+ p>agraph        
7#b77;,b77ii72 &  7,,ii7 by ins]t+ n    
e>li] ?an ,janu>y #a ( ! ye> t is #c    
ye>s aft] ! select$ drug publication    
date ( ! li/ on :i* ! biological product
 w\ld h be5 includ$ z a select$ drug b =
 a delay "u p>agraph 7#b77;,a7 aft] at  
su* "t2 &  7ii7 9 subp>agraph 7,b7--    
7,i7 9 clause 7i71 by /rik+ subclause   
7,i7 & ins]t+ ! foll[+3  7,i7 #ge p]c5t 
( ! am\nt by :i* ! av]age manufactur]   
price1 z report$ by ! manufactur] ( su* 
cov]$ "p ,d drug "u section #aibg 7or1  
if n report$ by su* manufactur] "u      
section #aibg1 z report$ by su*         
manufactur] to ! ,secret>y pursuant to !
 agreem5t "u section #aaic7;a77 = su*   
biological product1 ) respect to ea* ( !
 cal5d> qu>t]s ( ! price applicability  
p]iod t w\ld h appli$ b = ?is           

subsection2 exce$s-- 7aa7 = ! initial   
price applicability ye> t w\ld h appli$ 
b = a delay "u p>agraph 7#b77;,a71 !    
maximum fair price negotiat$ "u section 
#aaid = su* biological product "u su*   
agreem5t2 or  7bb7 = ! second ye> ( su* 
delay & ! rema9+ p]iod ( su* delay end+ 
on ,decemb] #ca ( ! ye> t is #b ye>s    
aft] ! select$ drug publication date ( !
 li/ on :i* ! biological product w\ld h 
be5 includ$ z a select$ drug b = a delay
 "u p>agraph 7#b77;,a71 su* maximum fair
 price1 increas$ z describ$ 9 section   
#aaie7;b77#a77;,a72 &  2 &  7,,ii7 9    
clause 7ii71 by /rik+ subclause 7,i7 &  
ins]t+ ! foll[+3  7,i7 #hj p]c5t ( !    
am\nt by :i* ! paym5t am\nt = su*       
biological product "u section           
#ahdg;,a7b71 ) respect to ea* ( ! cal5d>
 qu>t]s ( ! price applicability p]iod t 
w\ld h appli$ b = ?is subsection2       
exce$s-- 7aa7 = ! initial price         
applicability ye> t w\ld h appli$ b = a 
delay "u p>agraph 7#b77;,a71 ! maximum  
fair price negotiat$ "u section #aaid = 

su* biological product "u su* agreem5t2 
or  7bb7 = ! second ye> ( su* delay & ! 
rema9+ p]iod ( su* delay end+ on        
,decemb] #ca ( ! ye> t is #b ye>s aft] !
 select$ drug publication date ( ! li/  
on :i* ! biological product w\ld h be5  
includ$ z a select$ drug b = a delay "u 
p>agraph 7#b77;,a71 su* maximum fair    
price1 increas$ z describ$ 9 section    
#aaie7;b77#a77;,a72 &  2 &  7#c7 by add+
 at ! end ! foll[+ new subsection3  7g7 
,def9ition ( m>ket ,9 ?is section1 ! t]m
 m>ket means to introduce or deliv] a   
drug or biological product 7includ+ a   
biosimil> biological product7 =         
introduction into int]/ate comm]ce4  4  
7b7 ,con=m+ & te*nical am5dm5ts ,su*    
,act is am5d$-- 7#a7 9 section          
#aaib7;b77#c7 7#db ,u4,s4,c4            
#acbj;f-#a7;b77#c771 by /rik+           
subp>agraphs 7,b77ii77,i7 & 7,c77i7 (   
subsection 7f77#b7 & ins]t+ subsection  
7f77#b77;,b77ii72 &  7#b7 9 section     
#aaih7b7 7#db ,u4,s4,c4 #acbj;f-#g7b771 
by /rik+ #aaib7;f71 & ins]t+ #aaib7;f74 

7c7 ,effective date ,! am5dm5ts made by 
?is section %all apply ) respect to     
initial price applicability ye>s beg9n+ 
) initial price applicability ye> #bjbg4