,i  #aad? ,,congress  #a/ ,session  ,h4 
,r4 #aegf  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #bd1 #bjae ,mr4  
,burgess 7= himself1 ,mr4 ,butt]field1  
,mr4 ,a%=d1 & ,mr4 ,bilirakis7 introduc$
 ! foll[+ bill2 :i* 0 ref]r$ to !       
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to require a /udy by !         
,gov]nm5t ,acc\ntability ,(fice 7,,gao7 
to assess ! ,food & ,drug               
,adm9i/ration's curr5t regulatory pa?way
 = review+ g5]ic v]sions ( nonbiologic  
complex drug products1 & = o!r purposes4
  #a4 ,%ort title ,?is ,act may be cit$ 
z ! ,g5]ic ,complex ,drugs ,safety &    
,effectiv5ess = ,pati5ts ,act ( #bjae4  
#b4 ,,gao /udy ( sci5tific issues reg>d+
 ! curr5t regulatory pa?way = review+   
g5]ic v]sions ( c]ta9 complex drug      
products  7a7 ,/udy by ,,gao ,!         
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all conduct a /udy to det]m9e ! foll[+3
  7#a7 ,) respect to nonbiologic complex
 drug products t h n be5 fully *>act]iz$
 7z def9$ 9 subsection 7e77#a771 :e!r ! 

li/+ ( su* drugs z ref]5ce products 9   
g5]ic drug applications pres5ts unique  
*all5ges 9 meet+ approval /&>ds t are   
significantly diff]5t ?an ! *all5ges    
pres5t$ by g5]ic drug applications t li/
 small-molecule ref]5ce products4  7#b7 
,) respect to biological products t are 
)9 ! scope ( ! exception "u section     
#gjjb7;e77#b7 ( ,public ,law #aaa-adh   
7relat+ to tempor>y au?ority = !        
approval ( biological products "u       
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee771   
:e!r ! li/+ ( su* biological products z 
ref]5ce products 9 g5]ic drug           
applications pres5ts unique *all5ges 9  
meet+ approval /&>ds t are significantly
 diff]5t ?an ! *all5ges pres5t$ by g5]ic
 drug applications t li/ small-molecule 
ref]5ce products4  7#c7 ,if ! answ] to !
 "q "u p>agraph 7#a7 or 7#b7 is t       
significantly diff]5t *all5ges are      
pres5t$ = pati5ts :5 ref]5ce products   
are nonbiologic complex drug products t 
h n be5 fully *>act]iz$ or :5 ref]5ce   

products are biological products t are  
)9 ! scope ( ! exception "u section     
#gjjb7;e77#b7 ( ,public ,law #aaa-adh3  
7,a7 ,:at degree ( *>act]ization ( !    
propos$ g5]ic v]sion & ! ref]5ce product
 %\ld be requir$ 9 ord] to det]m9e !    
safety & effectiv5ess ( ! g5]ic v]sion4 
7,b7 ,:at degree ( simil>ity %\ld be    
requir$ to deem t ! active +r$i5t ( !   
propos$ g5]ic v]sion is ! same z !      
active +r$i5t ( ! ref]5ce product4  7,c7
 ,:at types ( evid5ce %\ld be requir$ to
 demon/rate t ! propos$ g5]ic v]sion is 
bioequival5t to ! ref]5ce product4  7,d7
 ,:at requirem5ts %\ld be e/abli%$ )    
respect to ! comp>ability ( !           
manufactur+ process = ! propos$ g5]ic   
v]sion & ! manufactur+ process = !      
ref]5ce product4  7,e7 ,:e!r & to :at   
ext5t cl9ical evid5ce is ne$$ to        
demon/rate t !re is no diff]5ce 9       
immunog5icity betwe5 ! propos$ g5]ic    
v]sion & ! ref]5ce product4  7,f7 ,:e!r 
& to :at ext5t o!r cl9ical evid5ce is   
ne$$ to demon/rate t ! propos$ g5]ic    

v]sion is z safe & effective = pati5ts z
 ! ref]5ce product4  7,g7 ,tak+ into    
acc\nt ! det]m9ations made reg>d+ !     
issues li/$ 9 subp>agraphs 7,a7 ?r\gh   
7,f73  7i7 ,:e!r section #eje7;j7 ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;j77 %\ld be am5d$  
to e/abli% provisions t expressly       
address ! approval ( copy v]sions (     
nonbiologic complex drug products t h n 
be5 fully *>act]iz$1 provisions t       
expressly address ! approval ( copy     
v]sions ( biological products t are )9 !
 scope ( ! exception "u section         
#gjjb7;e77#b7 ( ,public ,law #aaa-adh1  
or bo?4  7ii7 ,:e!r section #eje7;b77#b7
 ( su* ,act 7#ba ,u4,s4,c4 #cee7;b77#b77
 %\ld be s am5d$4  7iii7 ,:e!r su* ,act 
%\ld o!rwise be s am5d$4  7iv7 ,:e!r    
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7 %\ld be s     
am5d$4  7,h7 ,tak+ into acc\nt !        
det]m9ations made reg>d+ ! issues li/$ 9
 subp>agraphs 7,a7 ?r\gh 7,f71 & tak+   
into consid]ation all relevant          

guidances1 draft guidances1 & o!r ag5cy 
policy docum5ts--  7i7 :e!r ! ,food &   
,drug ,adm9i/ration %\ld develop &      
provide to ! public a policy docum5t t  
provides a compreh5sive /atem5t ( g5]al 
pr9ciples on ! evid5ce t is necess>y to 
obta9 ! approval ( su* ,adm9i/ration =  
propos$ g5]ic v]sions ( ref]5ce products
 t are nonbiologic complex drug products
 t h n be5 fully *>act]iz$ or t are     
biological products2 &  7ii7 if s1 !    
date by :i* su* ,adm9i/ration c\ld      
reasonably be expect$ to issue su*      
compreh5sive policy docum5t4  7b7       
,consultation ,! ,comptroll] ,g5]al %all
 conduct ! /udy "u subsection 7a7 9     
consultation )-- 7#a7 ! ,secret>y (     
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs2 &  7#b7  
appropriate public & private entities1  
includ+ pati5t advocacy organizations1  
pr(essional m$ical associations1        
hospital ph>macies1 sci5ti/s ( academic 
& bus9ess organizations1 &              
repres5tatives ( ! regulat$ indu/ry4    

7c7 ,requir$ consid]ation ,9 c>ry+ out !
 /udy "u subsection 7a71 ! ,comptroll]  
,g5]al %all consid] ! foll[+3  7#a7     
,publi%$ cl9ical reports ( cl9ically    
mean+ful 7includ+ s]i\s7 adv]se ev5ts ( 
pati5ts to--  7,a7 g5]ic v]sions ( !    
nonbiologic complex drug products t h n 
be5 fully *>act]iz$2  7,b7 g5]ic v]sions
 ( biological products2 &  7,c7 !       
ref]5ce products4  7#b7 ,! specific     
crit]ia t h be5 us$ by ! ,secret>y to   
approve g5]ic v]sions ( nonbiologic     
complex drug products t h n be5 fully   
*>act]iz$ or g5]ic v]sions ( biological 
products4  7#c7 ,! specific crit]ia     
specifi$ 9 guidances1 draft guidance1 & 
o!r docum5ts issu$ by ! ,secret>y reg>d+
 applications "u section #cea7k7 ( !    
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k77 = ! lic5s+ (         
biosimil> biological products4  7d7     
,optional consid]ation ,9 c>ry+ out !   
/udy "u subsection 7a71 ! ,comptroll]   
,g5]al may "u subsection 7c7 consid] !  
foll[+ in=mation f =eign c\ntries3  7#a7

 ,reports describ$ 9 subsection 7c77#a7 
f =eign c\ntries t are li/$ 9 clause 7i7
 or 7ii7 ( section #hjb7;b77#a77;,a7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #chb7;b77#a77;,a77 or are
 designat$ pursuant to section          
#hjb7;b77#a77;,b7 ( su* ,act 7#ba       
,u4,s4,c4 #chb7;b77#a77;,b774  7#b7 ,!  
guidel9es or recomm5dations ( !         
ph>maceutical regulatory ag5cies ( =eign
 c\ntries describ$ 9 p>agraph 7#a7      
reg>d+ any class ( products t su* an    
ag5cy regulates z a biosimil> biological
 product1 b t has be5 or c\ld be approv$
 z a g5]ic drug 9 ! ,unit$ ,/ates4  7#c7
 ,any in/ance :]e ! ,secret>y or su*    
=eign regulatory ag5cies h1 aft] approv+
 a g5]ic v]sion 7or a =eign equival5t7 (
 a nonbiologic complex drug product t   
has n be5 fully *>act]iz$ or a g5]ic    
v]sion 7or a =eign equival5t7 ( a       
biological product1 s\ght a cl9ical     
trial to confirm--  7,a7 ! g5]ic v]sion 
7or =eign equival5t7 is !rapeutically   
equival5t to ! ref]5ce product 7or meets

 a simil> /&>d1 9 ! case ( a =eign      
regulatory ag5cy72 or  7,b7 ! safety &  
effectiv5ess ( ! g5]ic v]sion 7or =eign 
equival5t74  7e7 ,completion date ,n    
lat] ?an ! expiration ( ! #b-ye> p]iod  
beg9n+ on ! date ( ! enactm5t ( ?is     
,act1 ! ,comptroll] ,g5]al %all complete
 ! /udy "u subsection 7a7 & submit a    
report describ+ ! f9d+s & conclusions ( 
! /udy to ! ,secret>y1 ! ,committee on  
,en]gy & ,comm]ce ( ! ,h\se (           
,repres5tatives1 & ! ,committee on      
,heal?1 ,education1 ,labor1 & ,p5sions (
 ! ,s5ate4  7f7 ,def9itions  7#a7       
,complex drug product n fully *>act]iz$ 
,= purposes ( ?is section1 ! t]ms       
complex drug product t has n be5 fully  
*>act]iz$ & complex drug products t h n 
be5 fully *>act]iz$1 ) respect to a     
nonbiologic drug1 means a drug = :i*--  
7,a7 ! active +r$i5t has molecul>       
div]sity2  7,b7 sci5tific analytic      
me?odologies are unable to fully id5tify
 ! molecul> /ructures & physio*emical   
prop]ties ( ! active +r$i5t2 &  7,c7 !  

nature ( ! active +r$i5t is n und]/ood  
suffici5tly to id5tity-- 7i7 all !      
molecul> compon5ts ( ! drug t are       
involv$ 9 produc+ ! !rapeutic effect2 & 
7ii7 ! me*anisms ( action t produce su* 
effect4  7#b7 ,o!r def9itions ,=        
purposes ( ?is section3  7,a7 ,! t]m    
bioequival5t1 ) respect to a g5]ic drug1
 has ! mean+ giv5 su* t]m 9 section     
#eje7;j77#h77;,b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#h77;,b774  7,b7 ,! t]m g5]ic  
drug or g5]ic v]sion1 ) respect to !    
,unit$ ,/ates1 means a drug t is approv$
 "u section #eje7;j7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j774  7,c7 ,! t]m g5]ic drug      
application means an abbreviat$         
application = ! approval ( a new drug "u
 section #eje7;j7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j774  7,d7 ,! t]m propos$1 )      
respect to a g5]ic v]sion1 means subject
 to a g5]ic drug application t is p5d+  
be=e ! ,food & ,drug ,adm9i/ration4     

7,e7 ,! t]m ref]5ce product1 ) respect  
to a g5]ic drug1 has ! mean+ giv5 ! t]m 
li/$ drug 9 section #eje7;j7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j774  7,f7 ,! t]m       
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices4