,i  #aafth ,,congress  #b;d ,session    
,h4 ,r4 #faee  ,,in ,,the ,,house ,,of  
,,representatives  ,march #i1 #bjbj,mr4 
,grothman introduced the following bill2
 which was referred to the ,committee on
 ,energy and ,commerce  ,a ,,bill  ,to  
amend the ,biologics ,price ,competition
 and ,innovation ,act of #bjji to make  
improvements with respect to the        
transition of biological products1 and  
for other purposes4  #a4 ,streamlining  
the transition of biological products   
7a7 ,continued review of certain        
applications ,section #gjjb7;e77#d77;,b7
 of the ,biologics ,price ,competition  
and ,innovation ,act of #bjji 7,public  
,law #aaa-adh7 is amended-- 7#a7 by     
striking clauses 7i71 7ii71 and 7vi72   
and  7#b7 by inserting before clause    
7iii7 the following3  7i7 ,in general   
,with respect to an application for a   
biological product submitted under      
subsection 7b7 or 7j7 of section #eje of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 that

 is filed not later than ,march #bc1    
#bjai1 and that is pending 7or          
tentatively approved7 as of ,march #bc1 
#bjbj-- 7,i7 the ,secretary shall       
continue to review such application     
under such section #eje1 even if such   
review continues after ,march #bc1      
#bjbj2 and  7,,ii7 upon approval of such
 application1 such application shall be 
deemed to be a license for the          
biological product under section #cea of
 the ,public ,health ,service ,act1     
pursuant to subparagraph 7,a71 and any  
period of exclusivity1 as applicable1   
shall be determined in accordance with  
such section4  7ii7 ,treatment of listed
 drugs ,with respect to a drug that is a
 biological product that has been deemed
 licensed under section #cea of the     
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bfb7 pursuant to subparagraph
 7,a7 and that is referenced in an      
application described in clause 7i71    
such drug shall-- 7,i7 continue to be   
identified as a listed drug on the list 

published pursuant to section           
#eje7;j77#g7 of the ,federal ,food1     
,drug1 and ,cosmetic ,act1 and the      
information for such drug on such list  
shall not be revised 7or removed7 unless
 and until the date on which each       
application described in clause 7i7 that
 references such drug is-- 7aa7 no      
longer pending review 7or the approval  
of such drug is tentative7 under section
 #eje of the ,federal ,food1 ,drug1 and 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 
7bb7 removed from such list in          
accordance with subparagraph 7,c7 of    
such section #eje7;j77#g72  7,,ii7 be   
subject only to requirements applicable 
to biological products licensed under   
section #cea of the ,public ,health     
,service ,act 7#db ,u4,s4,c4 #bfb72 and 
7,,iii7 be deemed to be a reference     
product under such section #cea on the  
date on which the last application      
described in clause 7i7 that references 
such drug is no longer pending review   
7or tentatively approved7 under section 

#eje of the ,federal ,food1 ,drug1 and  
,cosmetic ,act 7#ba ,u4,s4,c4 #cee74  4 
7b7 ,certain insulin products deemed    
interchangeable biosimilars ,section    
#gjjb7;e77#d7 of the ,biologics ,price  
,competition and ,innovation ,act of    
#bjji 7,public ,law #aaa-adh7 is amended
 by adding at the end the following3    
7,c7 ,certain insulin products deemed   
interchangeable biosimilars  7i7 ,in    
general ,in carrying out subparagraph   
7,a71 a covered insulin product shall be
 deemed to be an interchangeable        
biosimilar biological product licensed  
under section #cea7k7 of the ,public    
,health ,service ,act4  7ii7            
,definitions ,in this subparagraph3 7,i7
 ,the terms biosimilar and              
interchangeable have the meaning given  
such terms in section #cea7;i7 of the   
,public ,health ,service ,act4  7,,ii7  
,the term covered insulin product means 
a biological product 7including a       
chemically synthesized polypeptide7 that
 is-- 7aa7 an insulin product2 and  7bb7

 approved under section #eje of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act pursuant to an application         
submitted under subsection 7b77#b7 of   
such section4  4