,,ii  #aah? ,,congress  #a/ ,session    
,s4 #bcje  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #ac1 #bjbc,mr4   
,lee 7= himself1 ,mr4 ,lujn1 ,mr4       
,braun1 & ,mr4 ,vance7 introduc$ !      
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,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$esignat+ items 7aa7   
?r\gh 7cc7 z subclauses 7,i7 ?r\gh      
7,,iii71 respectively1 & adju/+ ! m>g9s 
accord+ly2 &  7iii7 by /rik+ 7,a7 ,9    
,g5]al & all t foll[s ?r\gh ,an         
application submitt$ "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,c7 ( ?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,c7 ( ?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+ 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 product4  7,b7
 ,congressional brief+ prior to c]ta9   
/udy requirem5ts ,! ,secret>y may       
require ! sponsor ( an application      
submitt$ "u ?is section to conduct a    
/udy to evaluate ! risk1 9 t]ms (       
safety1 purity1 or pot5cy1 ( alt]nat+ or
 swit*+ betwe5 ! use ( ! biological     
product t is ! subject ( ! application &
 ! ref]5ce product1 if1 be=e requir+ su*
 a /udy1 ! ,secret>y fir/ holds a       
private brief+ ) ! *air & rank+ memb] ( 
! ,committee on ,heal?1 ,education1     
,labor1 & ,p5sions ( ! ,s5ate & ! *air &
 ! rank+ memb] ( ! ,committee on ,en]gy 
& ,comm]ce ( ! ,h\se ( ,repres5tatives1 
to expla9 :y su* a /udy is necess>y = ! 
biological product1 :at in=mation !     
,secret>y expects su* a /udy to reveal1 
:at alt]natives to su* /udy h be5       
consid]$1 & :y ^? alt]natives are n     
suffici5t4  2  7#d7 by /rik+ p>agraph   
7#f72 &  7#e7 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 ,by am5d+ subsection 7l7 (  

section #eje;,b ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7
 to read z foll[s3  7l7 ,biosimil>      
biological products ,a biological       
product = :i* an application is submitt$
 "u section #cea7k7 ( ! ,public ,heal?  
,s]vice ,act %all be consid]$ to h a new
 active +r$i5t = purposes ( ?is section1
 except t a p$iatric assessm5t %all n be
 requir$ = a claim$ indication 9 a      
relevant p$iatric population if !       
assessm5t w\ld involve-- 7#a7 a         
condition ( use t has n be5 previ\sly   
approv$ = ! ref]5ce product2 or  7#b7 a 
dosage =m1 /r5g?1 or r\te ( adm9i/ration
 t diff]s f t ( ! ref]5ce product4  4   
7c7 ,application ,! am5dm5ts made by    
subsection 7a77#d7 to section           
#cea7k77#f7 ( ! ,public ,heal? ,s]vice  
,act 7#db ,u4,s4,c4 #bfb7k77#f77 %all   
apply only ) respect to applications    
approv$ "u section #cea7k7 ( su* ,act on
 or aft] ! date ( enactm5t ( ?is ,act4  
,any p]iod ( exclusivity grant$ "u      
section #cea7k77#f7 ( su* ,act ) respect

 to an application approv$ "u su*       
section #cea7k7 be=e ! date ( enactm5t (
 ?is ,act %all apply 9 accordance ) su* 
section #cea7k77#f71 z 9 effect on ! day
 be=e ! date ( enactm5t ( ?is ,act4