,,ii  #aaith ,,congress  #ast ,session  
,s4 #adad  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #aj1    
#bjbe,mr4 ,paul introduced the following
 bill2 which was read twice and referred
 to the ,committee on ,health1          
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to amend the ,public ,health   
,service ,act to provide that clinical  
studies required for licensure of       
biological products as biosimilar shall 
not be required to include the          
assessment of immunogenicity1           
pharmacodynamics1 or comparative        
clinical efficacy4  #a4 ,short title    
,this ,act may be cited as the          
,expedited ,access to ,biosimilars ,act4
  #b4 ,assessment of immunogenicity1    
pharmacodynamics1 or comparative        
clinical efficacy in clinical studies   
required for licensure of biological    
products as biosimilar  7a7 ,in general 
,section #cea7k77#b77;,a7 of the ,public
 ,health ,service ,act 7#db ,u4,s4,c4   
#bfb7k77#b77;,a77 is amended-- 7#a7 in  

clause 7i77,i7-- 7,a7 in item 7bb71 by  
striking and at the end2 and  7,b7 by   
striking item 7cc7 and inserting the    
following  7cc7 a clinical study or     
studies assessing pharmacokinetics that 
are sufficient to demonstrate safety1   
purity1 and potency2 and  7dd7 subject  
to clause 7iv71 a clinical study or     
studies that are sufficient to          
demonstrate safety1 purity1 and potency 
in #a or more appropriate conditions of 
use for which the reference product is  
licensed and intended to be used and for
 which licensure is sought for the      
biological product2  2 and  7#b7 by     
adding at the end the following3  7iv7  
,clinical studies  7,i7 ,in general     
,subject to subclause 7,,ii71 the       
,secretary may determine1 in the        
,secretary's discretion1 that a clinical
 study required under clause 7i77,i77dd7
 shall include the assessment of        
immunogenicity1 pharmacodynamics1 or    
comparative clinical efficacy4  7,,ii7  
,requirement ,the ,secretary may only   

require the assessment of               
immunogenicity1 pharmacodynamics1 or    
comparative clinical efficacy pursuant  
to a determination under subclause 7,i7 
if the ,secretary provides to the       
applicant notice of the requirement1    
including a written justification of the
 basis for such determination1 not later
 than the earliest date on which the    
applicant may file the application under
 this subsection4  4  7b7 ,applicability
 ,the amendments made by subsection 7a7 
shall apply with respect to an          
application submitted under section     
#cea7k7 of the ,public ,health ,service 
,act 7#db ,u4,s4,c4 #bfb7k77 on or after
 the date of enactment of this ,act4