,,ii  #aai? ,,congress  #a/ ,session    
,s4 #adad  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #aj1 #bjbe,mr4  
,paul introduc$ ! foll[+ bill2 :i* 0    
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,public ,heal?    
,s]vice ,act to provide t cl9ical /udies
 requir$ = lic5sure ( biological        
products z biosimil> %all n be requir$  
to include ! assessm5t ( immunog5icity1 
ph>macodynamics1 or comp>ative cl9ical  
efficacy4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,exp$it$ ,access to        
,biosimil>s ,act4  #b4 ,assessm5t (     
immunog5icity1 ph>macodynamics1 or      
comp>ative cl9ical 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 7bb71 by   
/rik+ & at ! end2 &  7,b7 by /rik+ item 
7cc7 & ins]t+ ! foll[+  7cc7 a cl9ical  

/udy or /udies assess+ ph>macok9etics t 
are suffici5t to demon/rate safety1     
purity1 & pot5cy2 &  7dd7 subject to    
clause 7iv71 a cl9ical /udy or /udies t 
are suffici5t to demon/rate safety1     
purity1 & pot5cy 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 ,cl9ical /udies  7,i7 ,9  
g5]al ,subject to subclause 7,,ii71 !   
,secret>y may det]m9e1 9 ! ,secret>y's  
discretion1 t a cl9ical /udy requir$ "u 
clause 7i77,i77dd7 %all include !       
assessm5t ( immunog5icity1              
ph>macodynamics1 or comp>ative cl9ical  
efficacy4  7,,ii7 ,requirem5t ,!        
,secret>y may only require ! assessm5t (
 immunog5icity1 ph>macodynamics1 or     
comp>ative cl9ical efficacy pursuant to 
a det]m9ation "u subclause 7,i7 if !    
,secret>y provides to ! applicant notice
 ( ! requirem5t1 includ+ a writt5       
ju/ification ( ! basis = su*            

det]m9ation1 n lat] ?an ! e>lie/ date on
 :i* ! applicant may file ! application 
"u ?is subsection4  4  7b7              
,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