,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #afha  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #bc 7legislative  
day1 ,may #bb71 #bjai,mr4 ,enzi 7=      
himself & ,ms4 ,hassan7 introduc$ !     
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,heal?1 ,education1  
,labor1 & ,p5sions  ,a ,,bill  ,to      
educate heal? c>e provid]s & ! public on
 biosimil> biological products1 & = o!r 
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,advanc+ ,education on     
,biosimil>s ,act ( #bjai4  #b4          
,education on biological products  7a7  
,9 g5]al ,subp>t #a ( "p ,f ( title     
,,iii ( ! ,public ,heal? ,s]vice ,act   
7#db ,u4,s4,c4 #bfb et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #ceb;,a4      
,education on biological products  7a7  
,int]net website  7#a7 ,9 g5]al ,!      
,secret>y %all e/abli%1 ma9ta91 & op]ate
 an int]net website consi/+ (           
educational mat]ials reg>d+ ! mean+ &   
use ( biosimil> biological products &   
int]*angeable biological products4  7#b7

 ,=mat ,! educational mat]ials provid$  
"u p>agraph 7#a7-- 7,a7 may be 9 ! =m ( 
web9>s1 cont9u+ m$ical education        
modules1 videos1 fact %eets1            
infographics1 /akehold] toolkits1 or o!r
 =mats1 z ! ,secret>y det]m9es          
appropriate2  7,b7 %all be pres5t$ 9 a  
mann]1 us+ simple t]m9ology1 t is easily
 compreh5d$ by appropriate t>get        
audi5ces1 includ+ acc\nt+1 to ! ext5t   
practicable1 = v>y+ levels ( heal?      
lit]acy among pati5ts & c>egiv]s2  7,c7 
%all be tailor$ = ! unique ne$s (       
appropriate t>get audi5ces1 includ+--   
7i7 heal? c>e provid]s ) prescrib+      
au?ority or disp5s+ au?ority "u         
applicable ,/ate law1 includ+           
physicians1 nurses1 nurse practition]s1 
physician assi/ants1 ph>maci/s1 &       
ph>macy te*nicians2 &  7ii7 pati5ts &   
c>egiv]s2 &  7,d7 may1 z appropriate1 be
 additionally tailor$ to heal? c>e      
provid]s practic+ 9 specialties 9 :i*   
biological products commonly are        
prescrib$ or to pati5t populations to   

:om biological products commonly are    
prescrib$ or adm9i/]$4  7#c7 ,cont5t    
,educational mat]ials provid$ "u        
p>agraph 7#a7 %all include explanations 
(-- 7,a7 key /atutory & regulatory      
def9itions1 includ+ ! def9itions ( !    
t]ms biosimil> & int]*angeable1 &       
cl>ification t an int]*angeable product 
is n sup]ior 9 quality to a biosimil>   
biological product2  7,b7 h[ ! ,secret>y
 det]m9es ! safety1 purity1 & pot5cy (  
biological products t are ! subjects (  
applications "u subsections 7a7 & 7k7 ( 
section #cea2  7,c7 ! application ( !   
same quality & manufactur+ /&>ds =      
biological products "u #cea7;a71        
biosimil> biological products "u        
#cea7k71 & int]*angeable biological     
products "u #cea7k77#d72  7,d7 !        
developm5t program & totality ( !       
evid5ce requir$ = biosimil> biological  
product developm5t & h[ prescrib]s c    
evaluate su* in=mation2  7,e7 ! process 
= report+ adv]se ev5ts = all biological 
products1 includ+ biosimil> &           

int]*angeable biological products2  7,f7
 ! relation%ip betwe5-- 7i7 v>iation    
among biological products lic5s$ "u     
section #cea7k7 & _! ref]5ce products   
lic5s$ "u section #cea7;a72 &  7ii7     
lot-to-lot v>iability = a biological    
product lic5s$ "u section #cea7;a7 or   
section #cea7k7 7includ+ int]*angeable  
biological products72  7,g7 h[ ! ,food &
 ,drug ,adm9i/ration assesses data      
reg>d+ ! risk ( immunog5icity =         
orig9ator biological products lic5s$ "u 
section #cea7;a7 & biosimil> biological 
products lic5s$ "u section #cea7k72     
7,h7 :e!r ! role ( analytical           
*>act]ization is novel to biosimil>     
biological product developm5t2 &  7,i7  
h[ ! ,food & ,drug ,adm9i/ration        
consid]s biosimil> biological products  
to be z safe & effective z _! ref]5ce   
products4  7#d7 ,o!r in=mation ,9       
addition to ! in=mation describ$ 9      
p>agraph 7#c71 ! int]net website        
e/abli%$ "u p>agraph 7#a7 %all include !
 foll[+ in=mation 7) r$actions z requir$

 by law = trade secret & confid5tial    
comm]cial in=mation71 z a s+le1 se>*able
 database3 7,a7 ,! action package ( ea* 
biological product lic5s$ "u subsection 
7a7 or 7k71 )9 #cj days ( approval ( !  
application1 or1 9 ! case ( a biological
 product lic5s$ be=e ! date ( enactm5t (
 ! ,advanc+ ,education on ,biosimil>s   
,act ( #bjai1 n lat] ?an #a ye> aft] su*
 date ( enactm5t4  7,b7 ,! summ>y review
 ( ea* biological product lic5s$ "u     
subsection 7a7 or 7k71 )9 #dh h\rs (    
approval ( ! application1 or1 9 ! case (
 a biological product lic5s$ be=e ! date
 ( enactm5t ( ! ,advanc+ ,education on  
,biosimil>s ,act ( #bjai1 n lat] ?an #a 
ye> aft] su* date ( enactm5t4  7,c7 ,!  
hi/ory & tim+ ( manufactur+ *anges )    
respect to biological products lic5s$ "u
 section #cea7;a74  7b7 ,cont9u+ m$ical 
education ,! ,secret>y %all advance     
education & aw>5ess among heal? c>e     
provid]s reg>d+ biosimil> biological    
products1 includ+ by develop+ or improv+
 cont9u+ m$ical education programs t    

advance ! education ( su* provid]s on ! 
prescrib+ (1 & relevant cl9ical         
consid]ations ) respect to1 biosimil>   
biological products4  4  7b7            
,application "u ! ,m$ic>e ,m]it-,bas$   
,inc5tive ,paym5t ,sy/em ,section       
#ahdh7q77#e77;,c7 ( ! ,social ,security 
,act 7#db ,u4,s4,c4                     
#aciew-#d7q77#e77;,c77 is am5d$ by add+ 
at ! end ! foll[+ new clause3  7iv7     
,cl9ical m$ical education program on    
biosimil> biological products           
,completion ( a cl9ical m$ical education
 program develop$ or improv$ "u section 
#ceb;,a7b7 ( ! ,public ,heal? ,s]vice   
,act by a ,,mips eligible pr(essional   
dur+ a p]=mance p]iod %all e>n su*      
eligible pr(essional "o-half ( ! highe/ 
pot5tial score = ! p]=mance category    
describ$ 9 p>agraph 7#b77;,a77iii7 = su*
 p]=mance p]iod4 ,a ,,mips eligible     
pr(essional may only c\nt ! completion (
 su* a program = purposes ( su* category
 "o "t dur+ ! eligible pr(essional's    
lifetime4  4