,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #iffa  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,july #ad1 #bjbf,mr4  
,langwor?y 7= himself & ,ms4 ,s*ri]7    
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,public ,heal?       
,s]vice ,act to codify t ! default      
expectation = lic5sure ( biological     
products z biosimil> does n include     
cl9ical /udies assess+ ph>macodynamics  
or comp>ative cl9ical efficacy1 & = o!r 
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,exp$it$ ,access to        
,biosimil>s ,act4  #b4 ,assessm5t (     
ph>macodynamics or efficacy 9 cl9ical   
/udies requir$ = lic5sure ( biological  
products z biosimil>  7a7 ,9 g5]al      
,section #cea7k77#b77;,a7 ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k77#b77;,a77 is am5d$--  7#a7 9    
clause 7i77,i7-- 7,a7 9 item 7bb7--  7i7
 by /rik+ item 7aa7 or 7cc7 & ins]t+    
item 7aa71 7cc71 or 7dd72 &  7ii7 by    
/rik+ & at ! end2 &  7,b7 by /rik+ item 

7cc7 & ins]t+ ! foll[+3  7cc7 an        
assessm5t ( ph>macok9etics &            
immunog5icity 7:i* may rely on1 or      
consi/ (1 a cl9ical ph>macok9etics /udy 
or /udies or a /udy or /udies describ$ 9
 item 7aa7 or 7dd71 z appropriate72 &   
7dd7 subject to clause 7iv71 an         
additional cl9ical /udy or /udies 9 #a  
or m appropriate conditions ( use = :i* 
! ref]5ce product is lic5s$ & int5d$ to 
be us$ & = :i* lic5sure is s\ght = !    
biological product2  2 &  7#b7 by add+  
at ! end ! foll[+3  7iv7 ,limitation on 
requir+ additional cl9ical /udy or      
/udies ,! ,secret>y may only require an 
additional cl9ical /udy or /udies       
describ$ 9 clause 7i77,i77dd71 includ+ a
 /udy or /udies t include an assessm5t (
 ph>macodynamics or efficacy1 if !      
,secret>y det]m9es t su* /udy or /udies 
are necess>y1 9 comb9ation ) ! o!r      
/udies describ$ 9 clause 7i77,i71 to    
demon/rate biosimil>ity & provides      
writt5 notice ( su* det]m9ation to !    
sponsor ( ! propos$ biosimil> biological

 product4 ,su* writt5 notice %all be    
provid$ n lat] ?an--  7,i7 ! date on :i*
 ! ,secret>y grants a reque/ = a        
biosimil> biological product developm5t 
meet+ f su* sponsor1 unless ! ,secret>y 
describes 9 writ+ :y an assessm5t ( !   
ne$ = su* /udy or /udies _c be made at t
 "t2 or  7,,ii7 if no reque/ = a        
biosimil> biological product developm5t 
meet+ is submitt$ or if ! ,secret>y 0   
unable to make ! assessm5t "u subclause 
7,i71 ! date t is #fj days aft] ! date (
 ! submission ( an application "u ?is   
subsection4  4  7b7  ,repeal (          
requirem5t relat+ ,to conduct ( reviews 
,section #cea7k77#e7 ( ! ,public ,heal? 
,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#e77
 is am5d$--  7#a7 by /rik+ subp>agraph  
7,b72 &  7#b7 by r$esignat+ subp>agraph 
7,c7 z subp>agraph 7,b74  7c7           
,applicability ,! am5dm5ts made by      
subsection 7a7 %all apply ) respect to  
an application submitt$ "u section      
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k77 on or aft] !    

date ( enactm5t ( ?is ,act4