,,ii  #aagth ,,congress  #b;d ,session  
,s4 #f  ,,in ,,the ,,senate ,,of ,,the  
,,united ,,states  ,november #ag1       
#bjbb,mr4 ,lee introduced the following 
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to improve the requirements for
 making a determination of              
interchangeability of a biological      
product and its reference product4  #a4 
,short title ,this ,act may be cited as 
the ,biosimilar ,red ,tape ,elimination 
,act4  #b4 ,biosimilar biological       
products ,section #cea7k7 of the ,public
 ,health ,service ,act 7#db ,u4,s4,c4   
#bfb7k77 is amended-- 7#a7 in paragraph 
7#b77;,a77i77,i77bb71 by striking 2 and 
and inserting 2 or2 and  7#b7 in        
paragraph 7#d7-- 7,a7 at the end of     
subparagraph 7,a77ii71 by striking 2 and
 and inserting a period2  7,b7 by       
striking sufficient to show and all that
 follows through 7,a7 the biological    
product-- and inserting sufficient to   

show that the biological product--2     
7,c7 by striking ,upon review of an and 
inserting the following3  7,a7 ,in      
general ,upon review of an  2 and  7,d7 
by amending subparagraph 7,b7 to read as
 follows3  7,b7 ,certain studies not    
required ,the ,secretary may not        
require1 for a determination of         
interchangeability described in         
subparagraph 7,a71 that a biological    
product undergo studies that assess the 
risks of alternating or switching       
between use of the biological product   
and the reference product4  4