,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #haij  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,septemb] #h1         
#bjbj,mr4 ,gro?man introduc$ ! foll[+   
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,public ,heal? ,s]vice ,act to deem any
 insul9 t is det]m9$ by ! ,secret>y to  
be biosimil> to ! ref]5ce product to be 
int]*angeable ) ! ref]5ce product1 & =  
o!r purposes4  #a4 ,%ort title ,?is ,act
 may be cit$ z ! ,biosimil> ,insul9     
,access ,act ( #bjbj4  #b4 ,deem+       
biosimil> insul9 to be int]*angeable    
7a7 ,9 g5]al ,section #cea7k77#c7 ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k77#c77 is am5d$ by add+ 
at ! end ! foll[+3  7,b7 ,biosimil>     
insul9  7i7 ,deem$ int]*angeable        
,not)/&+ p>agraph 7#d71 an insul9 is    
deem$ to be int]*angeable ) ! ref]5ce   
product if ! insul9 is det]m9$ by !     
,secret>y to be biosimil> to ! ref]5ce  
product4  7ii7 ,%ort5+ exclusivity =    
fir/ int]*angeable product  7,i7 ,action

 in/itut$ ,if an action is in/itut$ "u  
subsection 7l77#f7 aga9/ ! applicant t  
submitt$ ! application = an insul9 t is 
! fir/ approv$ int]*angeable biosimil>  
biological product1 p>agraph 7#f7 %all  
apply ) respect to su* insul9 )\t reg>d 
to p>agraph 7#f77;,a74  7,,ii7 ,action n
 in/itut$ ,if su* an action is n        
in/itut$ ) respect to an insul9 t is    
approv$ z an int]*angeable biosimil>    
biological product1 ! ,secret>y %all    
make a det]m9ation on ! int]*angeability
 ( any second or subsequ5t biological   
product )\t reg>d to ! delay o!rwise    
requir$ by p>agraph 7#f74  7iii7        
,applicability ,clause 7i7 applies )\t  
reg>d to :e!r ! insul9 is det]m9$ to be 
biosimil> to ! ref]5ce product1 or deem$
 to be lic5s$ pursuant to ?is section1  
be=e or aft] ! date ( enactm5t ( !      
,biosimil> ,insul9 ,access ,act ( #bjbj4
  4  7b7 ,con=m+ *anges ,section        
#cea7k77#c7 ( ! ,public ,heal? ,s]vice  
,act 7#db ,u4,s4,c4 #bfb7k77#c77 is     
am5d$-- 7#a7 by /rik+ ,^u review &      

ins]t+ ! foll[+3  7,a7 ,9 g5]al ,^u     
review  2  7#b7 by /rik+ 7,a7 !         
,secret>y & ins]t+ ! foll[+3  7i7 !     
,secret>y  2  7#c7 by /rik+ 7i7 is      
biosimil> & ins]t+ ! foll[+3  7,i7 is   
biosimil>  2  7#d7 by /rik+ 7ii7 c be & 
ins]t+ ! foll[+3  7,,ii7 c be  2 &  7#e7
 by /rik+ 7,b7 ! applicant & ins]t+ !   
foll[+3  7ii7 ! applicant  4