,,ii  #aagth ,,congress  #b;d ,session  
,s4 #dcjc  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #be1      
#bjbb,mr4 ,kaine 7for himself and ,ms4  
,collins7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,health1 ,education1  
,labor1 and ,pensions  ,a ,,bill  ,to   
provide for a period of exclusivity for 
first interchangeable biological        
products4  #a4 ,short title ,this ,act  
may be cited as the ,interchangeable    
,biologics ,clarity ,act4  #b4          
,clarifications to exclusivity          
provisions for first interchangeable    
biosimilar biological products ,section 
#cea7k77#f7 of the ,public ,health      
,service ,act 7#db ,u4,s4,c4            
#bfb7k77#f77 is amended-- 7#a7 in the   
matter preceding subparagraph 7,a7--    
7,a7 by striking ,upon review of and    
inserting ,the ,secretary shall not make
 approval effective of2  7,b7 by        
striking relying on and inserting for an
 interchangeable biological product that

 relies on2 and  7,c7 by striking the   
,secretary shall not make a             
determination under paragraph 7#d7 that 
the second or subsequent biological     
product is interchangeable for any      
condition of use2 and  7#b7 in the flush
 text that follows subparagraph 7,c71 by
 striking the period and inserting 1 and
 the term first interchangeable         
biosimilar biological product means any 
interchangeable biosimilar biological   
product that is approved on the first   
day on which such a product is approved 
as interchangeable with the reference   
product44