,i  #aafth ,,congress  #b;d ,session    
,h4 ,r4 #haij  ,,in ,,the ,,house ,,of  
,,representatives  ,september #h1       
#bjbj,mr4 ,grothman introduced the      
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to amend the ,public ,health
 ,service ,act to deem any insulin that 
is determined by the ,secretary to be   
biosimilar to the reference product to  
be interchangeable with the reference   
product1 and for other purposes4  #a4   
,short title ,this ,act may be cited as 
the ,biosimilar ,insulin ,access ,act of
 #bjbj4  #b4 ,deeming biosimilar insulin
 to be interchangeable  7a7 ,in general 
,section #cea7k77#c7 of the ,public     
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7k77#c77 is amended by adding at the
 end the following3  7,b7 ,biosimilar   
insulin  7i7 ,deemed interchangeable    
,notwithstanding paragraph 7#d71 an     
insulin is deemed to be interchangeable 
with the reference product if the       
insulin is determined by the ,secretary 

to be biosimilar to the reference       
product4  7ii7 ,shortening exclusivity  
for first interchangeable product  7,i7 
,action instituted ,if an action is     
instituted under subsection 7l77#f7     
against the applicant that submitted the
 application for an insulin that is the 
first approved interchangeable          
biosimilar biological product1 paragraph
 7#f7 shall apply with respect to such  
insulin without regard to paragraph     
7#f77;,a74  7,,ii7 ,action not          
instituted ,if such an action is not    
instituted with respect to an insulin   
that is approved as an interchangeable  
biosimilar biological product1 the      
,secretary shall make a determination on
 the interchangeability of any second or
 subsequent biological product without  
regard to the delay otherwise required  
by paragraph 7#f74  7iii7 ,applicability
 ,clause 7i7 applies without regard to  
whether the insulin is determined to be 
biosimilar to the reference product1 or 
deemed to be licensed pursuant to this  

section1 before or after the date of    
enactment of the ,biosimilar ,insulin   
,access ,act of #bjbj4  4  7b7          
,conforming changes ,section #cea7k77#c7
 of the ,public ,health ,service ,act   
7#db ,u4,s4,c4 #bfb7k77#c77 is amended--
 7#a7 by striking ,upon review and      
inserting the following3  7,a7 ,in      
general ,upon review  2  7#b7 by        
striking 7,a7 the ,secretary and        
inserting the following3  7i7 the       
,secretary  2  7#c7 by striking 7i7 is  
biosimilar and inserting the following3 
7,i7 is biosimilar  2  7#d7 by striking 
7ii7 can be and inserting the following3
  7,,ii7 can be  2 and  7#e7 by striking
 7,b7 the applicant and inserting the   
following3  7ii7 the applicant  4