,,ii  #aai? ,,congress  #b;d ,session   
,s4 #eega  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #bh1         
#bjbf,mrs4 ,blackburn 7= h]self1 ,mr4   
,s*iff1 ,mr4 ,lank=d1 & ,mr4 ,budd7     
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$-- 7#a7 9 
subsection 7c7-- 7,a7 9 p>agraph 7#a71 9
 ! matt] prec$+ subp>agraph 7,a71 by    
/rik+ su* ye> & ea* subsequ5t ye> beg9n+
 be=e ! fir/ ye> t beg9s at lea/ #i     
mon?s & ins]t+ ! ye> ( ! select$ drug   
publication date = su* initial price    
applicability ye> & ea* subsequ5t ye>1  

except t a drug or biological product   
%all no long] be a select$ drug beg9n+  
on ! fir/ day ( ! ye> t beg9s2 &  7,b7 9
 p>agraph 7#b7-- 7i7 9 subp>agraph 7,b71
 by /rik+ or dur+ ! negotiation p]iod ) 
respect to su* initial price            
applicability ye> & ins]t+ ! fir/ day ( 
su* initial price applicability ye>2 &  
7ii7 9 ! flu% text foll[+ subp>agraph   
7,b7-- 7,i7 by /rik+ & %all cont9ue to &
 ins]t+ if su* negotiation p]iod has n  
yet end$1 %all n h its maximum fair     
price or ! explanation ( su* maximum    
fair price publi%$ "u section #aaie7;a7 
if su* publication has n yet occurr$1 & 
%all2  7,,ii7 by ins]t+ solely be=e )   
respect to ! numb]2 &  7,,iii7 by ins]t+
 1 b no maximum fair price %all apply = 
su* initial price applicability ye> 9   
accordance ) p>agraph 7#a7 be=e ! p]iod 
at ! end2  7#b7 9 subsection 7f7-- 7,a7 
9 p>agraph 7#a7-- 7i7 9 subp>agraph     
7,a71 by /rik+ an ext5d$ monopoly drug  
7z def9$ 9 section #aaid7;c77#d72  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$7 !     
foll[+3  7i7 ,automatic delay  7,i7 ,9  
g5]al ,! ,secret>y %all apply1 ) respect
 to a biological product describ$ 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;,a7-- 7aa7 ! 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,,aa7 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 or 7,,bb7 t su*   
manufactur]'s cl9ical /udy or /udies ( !
 biosimil> biological product z describ$
 9 section #cea7k77#b77;,a77i77,i77cc7 (
 ! ,public ,heal? ,s]vice ,act 7        
initiat$ & rema9 ongo+1 are complete1 or
 t no su* /udy or /udies are necess>y2 &
  7bb7 subject to subclause 7,,ii71 bas$
 on in=mation submitt$ to ! ,secret>y by
 any p]son or obta9$ by ! ,secret>y f   
any o!r s\rce1 ! ,secret>y det]m9es t ! 
manufactur] ( ! biosimil> biological    
product expects t su* product w be      
m>ket$ be=e ! date t is #b ye>s aft] !  
select$ drug publication date ) respect 
to su* initial price applicability ye>4 
7,,ii7 ,requirem5ts  7aa7 ,9 g5]al ,be=e
 mak+ ! det]m9ation describ$ 9 subclause
 7,,ii77bb71 ! ,secret>y %all-- 7,,aa7  
in=m ! manufactur] ( ! biosimil>        
biological product ( ! in=mation on :i* 
! ,secret>y int5ds to rely 9 mak+ su*   

det]m9ation2 & 7,,bb7 require t su*     
manufactur] confirms 9 writ+1 "u p5alty 
( p]jury1 ! accuracy ( su* in=mation or 
corrects any su* inaccurate in=mation1  
includ+ its expect$ m>ket+ date4  7bb7  
,cl>ification ,! exi/5ce ( p5d+ or      
prospective pat5t litigation ov] a      
biosimil> biological product %all n     
preclude application ( ! rules describ$ 
9 subp>agraph 7,a7 ( p>agraph 7#b7      
7subject to p>agraphs 7,b7 & 7,c7 ( su* 
p>agraph74  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,i77bb71 by ins]t+ to ! ext5t
 available1 be=e all agreem5ts2 &  7dd7 
9 subclause 7,,iii77bb7-- 7,,aa7 by     
ins]t+ ! anticipat$ laun* date be=e     
capital inve/m5t2 & 7,,bb7 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 
su* biological product is n ! ref]5ce   
product = a biosimil> biological product
 t has 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 ! date 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$7-- 7,i7 by /rik+ clauses 7ii7
 & 7iii72  7,,ii7 by r$esignat+ clause  
7iv7 z clause 7ii72 &  7,,iii7 9 clause 
7ii77,,ii7 7z s r$esignat$71 by /rik+   
p>agraph 7#a77;,b77ii77,i77bb7 & ins]t+ 
p>agraph 7#a77;,b77iii77,i77bb72  7,c7  
by /rik+ p>agraph 7#c7 & ins]t+ !       
foll[+3  7#c7 ,high likelihood  7,a7 ,9 
g5]al ,subject to subp>agraph 7,b71 =   
purposes ( ?is subsection1 !re is a high
 likelihood describ$ 9 p>agraph 7#a7 or 
p>agraph 7#b71 z applicable1 if !       
,secret>y det]m9es t in=mation submitt$ 
to ! ,secret>y by any p]son or obta9$ by
 ! ,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$4  7,b7 ,det]m9ation requirem5ts  
,be=e det]m9+ :e!r !re is a high        
likelihood describ$ 9 p>agraph 7#a7 or  
p>agraph 7#b71 ! ,secret>y %all in=m !  
manufactur] ( ! biosimil> biological    
product ( ! in=mation on :i* ! ,secret>y
 int5ds to rely 9 mak+ su* det]m9ation &
 %all require t su* manufactur] confirms
 9 writ+1 "u p5alty ( p]jury1 ! accuracy
 ( su* in=mation or correct any su*     
inaccurate in=mation4  7,c7             
,cl>ification ,! exi/5ce ( p5d+ or      
prospective pat5t litigation reg>d+ !   
biosimil> biological product %all n     
preclude a f9d+ ( high likelihood "u ?is
 p>agraph4  2 &  7,d7 9 p>agraph 7#d7-- 
7i7 9 subp>agraph 7,a71 by /rik+        
subp>agraphs 7,b77ii77,,ii7 & 7,c77ii7 (
 p>agraph 7#b7 & ins]t+ p>agraph        
7#b77;,b77ii72 &  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* delay1 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* delay1 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$ means1 )      
respect to a drug or biological product 
7includ+ a biosimil> biological product7
 introduc$ or deliv]$ = introduction    
into int]/ate comm]ce4  4  7b7 ,con=m+ &
 te*nical am5dm5ts ,su* ,act is am5d$-- 
7#a7 9 section #aaib7;b77#c7 7#db       
,u4,s4,c4 #acbj;f-#a7;b77#c77-- 7,a7 by 
/rik+ subp>agraphs 7,b77ii77,i7 &       
7,c77i7 ( subsection 7f77#b7 & ins]t+   
subsection 7f77#b77;,b77i72 &  7,b7 by  
/rik+ describ$ 9 su* subp>agraphs &     
ins]t+ describ$ 9 su* subsection2 &     
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> #bjbf4