,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #faee  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #i1 #bjbj,mr4    
,gro?man introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to am5d !         
,biologics ,price ,competition &        
,innovation ,act ( #bjji to make        
improvem5ts ) respect to ! transition ( 
biological products1 & = o!r purposes4  
#a4 ,/reaml9+ ! transition ( biological 
products  7a7 ,cont9u$ review ( c]ta9   
applications ,section #gjjb7;e77#d77;,b7
 ( ! ,biologics ,price ,competition &   
,innovation ,act ( #bjji 7,public ,law  
#aaa-adh7 is am5d$-- 7#a7 by /rik+      
clauses 7i71 7ii71 & 7vi72 &  7#b7 by   
ins]t+ be=e clause 7iii7 ! foll[+3  7i7 
,9 g5]al ,) respect to an application = 
a biological product submitt$ "u        
subsection 7b7 or 7j7 ( section #eje ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cee7 t is fil$ n lat]   
?an ,m>* #bc1 #bjai1 & t is p5d+ 7or    
t5tatively approv$7 z ( ,m>* #bc1       

#bjbj-- 7,i7 ! ,secret>y %all cont9ue to
 review su* application "u su* section  
#eje1 ev5 if su* review cont9ues aft]   
,m>* #bc1 #bjbj2 &  7,,ii7 ^u approval (
 su* application1 su* application %all  
be deem$ to be a lic5se = ! biological  
product "u section #cea ( ! ,public     
,heal? ,s]vice ,act1 pursuant to        
subp>agraph 7,a71 & any p]iod (         
exclusivity1 z applicable1 %all be      
det]m9$ 9 accordance ) su* section4     
7ii7 ,treatm5t ( li/$ drugs ,) respect  
to a drug t is a biological product t   
has be5 deem$ lic5s$ "u section #cea ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb7 pursuant to subp>agraph 
7,a7 & t is ref]5c$ 9 an application    
describ$ 9 clause 7i71 su* drug %all--  
7,i7 cont9ue to be id5tifi$ z a li/$    
drug on ! li/ publi%$ pursuant to       
section #eje7;j77#g7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act1 & ! in=mation =
 su* drug on su* li/ %all n be revis$   
7or remov$7 unless & until ! date on :i*
 ea* application describ$ 9 clause 7i7 t

 ref]5ces su* drug is-- 7aa7 no long]   
p5d+ review 7or ! approval ( su* drug is
 t5tative7 "u section #eje ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee72 or  7bb7 remov$ f su*  
li/ 9 accordance ) subp>agraph 7,c7 (   
su* section #eje7;j77#g72  7,,ii7 be    
subject only to requirem5ts applicable  
to biological products lic5s$ "u section
 #cea ( ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #bfb72 &  7,,iii7 be     
deem$ to be a ref]5ce product "u su*    
section #cea on ! date on :i* ! la/     
application describ$ 9 clause 7i7 t     
ref]5ces su* drug is no long] p5d+      
review 7or t5tatively approv$7 "u       
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee74  4 
7b7 ,c]ta9 insul9 products deem$        
int]*angeable biosimil>s ,section       
#gjjb7;e77#d7 ( ! ,biologics ,price     
,competition & ,innovation ,act ( #bjji 
7,public ,law #aaa-adh7 is am5d$ by add+
 at ! end ! foll[+3  7,c7 ,c]ta9 insul9 
products deem$ int]*angeable biosimil>s 

7i7 ,9 g5]al ,9 c>ry+ out subp>agraph   
7,a71 a cov]$ insul9 product %all be    
deem$ to be an int]*angeable biosimil>  
biological product lic5s$ "u section    
#cea7k7 ( ! ,public ,heal? ,s]vice ,act4
  7ii7 ,def9itions ,9 ?is subp>agraph3  
7,i7 ,! t]ms biosimil> & int]*angeable h
 ! mean+ giv5 su* t]ms 9 section        
#cea7;i7 ( ! ,public ,heal? ,s]vice     
,act4  7,,ii7 ,! t]m cov]$ insul9       
product means a biological product      
7includ+ a *emically syn!siz$           
polypeptide7 t is-- 7aa7 an insul9      
product2 &  7bb7 approv$ "u section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act pursuant to an application submitt$
 "u subsection 7b77#b7 ( su* section4  4