,,ii  #aah? ,,congress  #a/ ,session    
,s4 #aebb  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #aj1 #bjbc,mr4    
,m>%all introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to require ! ,secret>y (    
,heal? & ,human ,s]vices to conduct a   
/udy on ! designation ( biosimil>       
biological products z int]*angeable4    
#a4 ,/udy on ! sub/itution (            
int]*angeable biological products  7a7  
,report on biosimil> biological product 
int]*angeability ,n lat] ?an #d ye>s    
aft] ! date ( enactm5t ( ?is ,act1 !    
,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is section z ! ,secret>y71
 act+ ?r\gh ! ,commission] ( ,food &    
,drugs1 %all submit to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate & ! ,committee on ,en]gy &    
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report on ! designation ( biosimil>     
biological products z int]*angeable1 "u 
section #cea7k77#d7 ( ! ,public ,heal?  

,s]vice ,act 7#db ,u4,s4,c4             
#bfb7k77#d774 ,su* report %all-- 7#a7   
describe any *all5ges fac$ by           
manufactur]s 9 develop+ & obta9+        
approval "u section #cea7k7 ( su* ,act =
 biosimil> biological products t receive
 su* int]*angeability designation2  7#b7
 summ>ize ! exp]i5ce ( ! ,food & ,drug  
,adm9i/ration 9 review+ applications =  
biosimil> biological products t seek an 
int]*angeability designation1 includ+   
comp>$ to applications = biosimil>      
biological products "u su* section      
#cea7k7 t d n seek su* designation2     
7#c7 summ>ize1 at a high level1 ! data &
 in=mation t ! ,food & ,drug            
,adm9i/ration has review$ to support    
applications = int]*angeability "u      
section #cea7k77#d7 ( su* ,act1 includ+ 
data f swit*+ /udies1 & ! diff]5ces     
betwe5 ! f9d+s f su* data & in=mation   
comp>$ to ! data & in=mation t ! ,food &
 ,drug ,adm9i/ration has review$ =      
biosimil> biological products t h n     
receiv$ a designation (                 

int]*angeability2  7#d7 describe ! exi/+
 au?ority ( ! ,food & ,drug             
,adm9i/ration to det]m9e1 on a          
case-by-case basis1 ! evid5ce ne$$ to   
support an int]*angeability designation1
 & h[ ! ,food & ,drug ,adm9i/ration has 
us$ su* au?ority1 includ+ ! factors t ! 
ag5cy may consid] :5 mak+ ^? judgem5ts2 
7#e7 describe h[ ! ,food & ,drug        
,adm9i/ration has consid]$ real-_w      
evid5ce or o!r data & in=mation1 includ+
 f use ( ! biological product 9 o!r     
c\ntries1 9 det]m9+ :e!r a biosimil>    
biological product meets ! crit]ia = !  
int]*angeability designation2  7#f7     
describe ! diff]5ces betwe5 ! regulatory
 & sci5tific consid]ations = det]m9+ a  
biological product to be int]*angeable  
"u section #cea7k77#d7 ( su* ,act 7#db  
,u4,s4,c4 #bfb7k77#d77 & ! sy/em =      
assign+ !rapeutic equival5ce rat+s to   
drugs approv$ "u section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee72 &  7#g7 assess ! uptake
 ( biosimil> biological products1 & !   

impact ( ! ef=ts ( ! ,food & ,drug      
,adm9i/ration to improve adoption (     
biosimil> biological products ?r\gh     
multim$ia education & curriculum        
mat]ials4  7b7 ,/akehold] input ,=      
purposes ( develop+ ! report describ$ 9 
subsection 7a71 ! ,secret>y may conv5e  
work%ops or li/5+ sessions1 e/abli%     
dockets to receive public comm5t1 or use
 o!r means to obta9 input f int]e/$     
/akehold]s4  7c7 ,in=mation disclosure  
,no?+ 9 ?is section %all be con/ru$ to  
au?orize ! disclosure ( in=mation t is  
prohibit$ f disclosure "u section       
#cja7;j7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cca7;j77 
or section #aije ( title #ah1 ,unit$    
,/ates ,code1 or subject to )hold+ "u   
p>agraph 7#d7 ( section #eeb7;b7 ( title
 #e1 ,unit$ ,/ates ,code 7commonly      
ref]r$ to z ! ,fre$om ( ,in=mation      
,act74