,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #eebf  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,septemb] #ai1        
#bjbe,mr4 ,pflug] 7= himself & ,mr4     
,l&sman7 introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to improve !      
requirem5ts = mak+ a det]m9ation (      
int]*angeability ( a biological product 
& its ref]5ce product4  #a4 ,%ort title 
,?is ,act may be cit$ z ! ,biosimil> ,r$
 ,tape ,elim9ation ,act4  #b4 ,biosimil>
 biological products  7a7 ,9 g5]al      
,section #cea7k7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 is 
am5d$--  7#a7 9 ! subsection head+1 by  
/rik+ or int]*angeable2  7#b7 9 p>agraph
 7#b7--  7,a7 by /rik+ subp>agraph 7,b72
  7,b7 by r$esignat+ clauses 7ii7 &     
7iii7 ( subp>agraph 7,a7 z subp>agraphs 
7,b7 & 7,c71 respectively1 & adju/+ !   
m>g9s accord+ly2  7,c7 9 subp>agraph    
7,a7-- 7i7 9 clause 7i71 by r$esignat+  
subclauses 7,i7 ?r\gh 7,v7 z clauses 7i7
 ?r\gh 7v71 respectively1 & adju/+ !    

m>g9s accord+ly2  7ii7 9 clause 7i71 z s
 r$esignat$ by clause 7i7 ( ?is         
subp>agraph1 by r$esignat+ items 7aa7   
?r\gh 7cc7 z subclauses 7,i7 ?r\gh      
7,,iii71 respectively1 & adju/+ ! m>g9s 
accord+ly2  7iii7 9 subclause 7,,ii7 (  
clause 7i71 z s r$esignat$ by clause    
7ii7 ( ?is subp>agraph1 by /rik+ item   
7aa7 or 7cc7 & ins]t+ subclause 7,i7 or 
7,,iii72 &  7iv7 by /rik+ 7,a7 ,9 ,g5]al
 & all t foll[s ?r\gh ,an application   
submitt$ "u ?is subsection %all include 
in=mation & ins]t+ ! foll[+3  7,a7 ,9   
g5]al ,an application submitt$ "u ?is   
subsection %all include in=mation  2    
7,d7 9 subp>agraph 7,b71 z s r$esignat$ 
by subp>agraph 7,b7 ( ?is p>agraph1 by  
/rik+ clause 7i77,i7 & ins]t+           
subp>agraph 7,a77i72 &  7,e7 9          
subp>agraph 7,c71 z s r$esignat$ by     
subp>agraph 7,b7 ( ?is p>agraph1 by     
r$esignat+ subclauses 7,i7 ?r\gh 7,,iii7
 z clauses 7i7 ?r\gh 7iii71             
respectively1 & by adju/+ ! m>g9s       
accord+ly2  7#c7 by am5d+ subp>agraph   

7,a7 ( p>agraph 7#c7 to read z foll[s3  
7,a7 ! ,secret>y det]m9es t ! in=mation 
submitt$ 9 ! application 7or !          
supplem5t7 is suffici5t to %[ t !       
biological product is biosimil> to !    
ref]5ce product2 &  2  7#d7 by am5d+    
p>agraph 7#d7 to read z foll[s3  7#d7   
,int]*angeability  7,a7 ,9 g5]al ,a     
biological product lic5s$ "u ?is        
subsection %all be deem$ to be          
int]*angeable ) ! ref]5ce product1      
subject to subp>agraph 7,b74  7,b7 ,tim+
 ( deem$ int]*angeability  7i7 ,lic5sure
 on or aft] transition date ,a          
biological product lic5s$ "u ?is        
subsection on or aft] ! transition date 
describ$ 9 subp>agraph 7,c7 7ref]r$ to 9
 ?is clause z ! applicable biological   
product7 %all be deem$ to be            
int]*angeable ) ! ref]5ce product ^u su*
 lic5sure1 unless ! applicable          
biological product reli$ on ! same      
ref]5ce product z ano!r biological      
product = :i*-- 7,i7 lic5sure "u ?is    
subsection 0 9 effect on ! day be=e !   

date ( enactm5t ( ! ,biosimil> ,r$ ,tape
 ,elim9ation ,act2 &  7,,ii7 a fir/     
int]*angeable exclusivity p]iod "u      
p>agraph 7#f7 7z 9 effect on ! day be=e 
! date ( enactm5t ( ! ,biosimil> ,r$    
,tape ,elim9ation ,act7 is 9 effect on !
 date ( lic5sure ( ! applicable         
biological product1  9 :i* case !       
applicable biological product %all be   
deem$ int]*angeable ) ! ref]5ce product 
"u ?is p>agraph on ! date on :i* !      
exclusivity p]iod describ$ 9 subclause  
7,,ii7 ends4  7ii7 ,lic5sure prior to   
transition date ,a biological product   
lic5s$ "u ?is subsection prior to !     
transition date describ$ 9 subp>agraph  
7,c7 7ref]r$ to 9 ?is clause z !        
applicable biological product7 %all be  
deem$ to be int]*angeable ) ! ref]5ce   
product on su* transition date1 unless !
 applicable biological product reli$ on 
! same ref]5ce product z ano!r          
biological product = :i*--  7,i7        
lic5sure "u ?is subsection 0 9 effect on
 ! day be=e ! date ( enactm5t ( !       

,biosimil> ,r$ ,tape ,elim9ation ,act2 &
  7,,ii7 a fir/ int]*angeable           
exclusivity p]iod "u p>agraph 7#f7 7z 9 
effect on ! day be=e ! date ( enactm5t (
 ! ,biosimil> ,r$ ,tape ,elim9ation     
,act7 is 9 effect on ! transition date1 
9 :i* case ! applicable biological      
product %all be deem$ int]*angeable ) ! 
ref]5ce product "u ?is p>agraph on !    
date on :i* ! exclusivity p]iod describ$
 9 subclause 7,,ii7 ends4  7,c7         
,transition date ,! transition date     
describ$ 9 ?is subp>agraph is ! date t  
is #fj days aft] ! date ( enactm5t ( !  
,biosimil> ,r$ ,tape ,elim9ation ,act4  
2  7#e7 by am5d+ p>agraph 7#f7 to read z
 foll[s3  7#f7 ,transition ) respect to 
pres]v+ fir/ int]*angeable exclusivity )
 respect to c]ta9 biological products ,)
 respect to a biological product lic5s$ 
"u ?is subsection be=e ! date ( enactm5t
 ( ! ,biosimil> ,r$ ,tape ,elim9ation   
,act1 = :i* !re 0 an unexpir$ p]iod (   
fir/ int]*angeable exclusivity "u ?is   
subsection 7z !n 9 effect71 su* unexpir$

 exclusivity p]iod %all rema9 9 effect =
 ! duration ( su* p]iod4  2 &  7#f7 9   
p>agraph 7#h77;,d7--  7,a7 9 clause 7i71
 by /rik+ class2 & & ins]t+ class42     
7,b7 by /rik+ clause 7ii72 &  7,c7 by   
/rik+ description (-- & all t foll[s    
?r\gh crit]ia t ! ,secret>y & ins]t+    
description ( ! crit]ia t ! ,secret>y4  
7b7 ,con=m+ am5dm5ts  7#a7 ,section     
#cea7;i77#c7 ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7;i77#c77 is    
am5d$ by /rik+ t is %[n to meet ! /&>ds 
describ$ 9 subsection 7k77#d7 & ins]t+  
lic5s$ "u subsection 7k74  7#b7 ,section
 #ceb;,a ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfc-a7 is am5d$ by     
/rik+ & int]*angeable biosimil>         
biological products ea* place x appe>s4 
7#c7 ,section #gdd;,g7#ad7 ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cgi;j-#ea7ad77 is am5d$ by   
/rik+ 1 includ+ a supplem5t reque/+ t ! 
,secret>y det]m9e t ! biosimil>         
biological product meets ! /&>ds =      
int]*angeability describ$ 9 section     

#cea7k77#d7 ( ! ,public ,heal? ,s]vice  
,act4  7#d7 ,section #eje;,b7l7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee;c7l77 to read z     
foll[s3  7l7 ,biosimil> biological      
products ,a biological product = :i* an 
application is submitt$ "u section      
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
%all n be consid]$ to h a new active    
+r$i5t = purposes ( ?is section1 unless 
! application seeks lic5sure =--  7#a7 a
 claim$ indication t has be5 approv$ = !
 ref]5ce product 9 a relevant p$iatric  
population or = :i* !re is a def]ral ( !
 p$iatric assessm5t "u p>agraph 7#d7 = !
 ref]5ce product2 &  7#b7 ! assessm5t   
w\ld n involve ! developm5t ( a         
biological product ) a /r5g?1 dosage =m1
 r\te ( adm9i/ration1 or condition ( use
 t c\ld n be lic5s$ "u section #cea7k7 (
 ! ,public ,heal? ,s]vice ,act4  4  7c7 
,guidance ,! ,secret>y %all-- 7#a7 n    
lat] ?an #ah mon?s aft] ! date (        
enactm5t ( ?is ,act1 update exi/+ draft 
& f9al guidance to reflect ! am5dm5ts   

made by ?is ,act1 includ+ by revis+ or  
revok+ ! guidance docum5t titl$         
,consid]ations 9 ,demon/rat+            
,int]*angeability ,) a ,ref]5ce ,product
 7,may #bjai7 & ,consid]ations 9        
,demon/rat+ ,int]*angeability ,) a      
,ref]5ce ,product3 ,update 7,june       
#bjbd72  7#b7 n lat] ?an #ah mon?s aft] 
! date ( enactm5t ( ?is ,act1 issue or  
revise guidance on review & approval (  
biosimil> biological products "u section
 #cea7k7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7k77 relat+ to !    
data & in=mation t an applicant is      
requir$ to submit to support a          
det]m9ation t a biosimil> biological    
product t is ! subject ( an application 
"u su* section is biosimil> to ! ref]5ce
 product 7z def9$ 9 section #cea7;i7 (  
su* ,act 7#db ,u4,s4,c4 #bfb7;i7772 &   
7#c7 n lat] ?an #ah mon?s aft] ! comm5t 
p]iod closes on ! guidance "u p>agraphs 
7#a7 & 7#b71 issue revis$ draft or f9al 
v]sions ( su* guidances4  7d7 ,rules (  
con/ruction ,! am5dm5ts made by ?is     

section %all n be con/ru$-- 7#a7 to alt]
 ! /&>d or ! in=mation requir$ =        
lic5sure ( a biological product z       
biosimil> to a ref]5ce product pursuant 
to section #cea7k7 ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 or
  7#b7 to limit ! in=mation t may be    
requir$ by ! ,secret>y ( ,heal? & ,human
 ,s]vices to support ! lic5sure ( a     
biological product z biosimil> to a     
ref]5ce product pursuant to su* section4