,i #aag? ,,congress #b;d ,session ,h4 ,r4 #hhgg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,septemb] #ai1 #bjbb,mrs4 ,mill]-,meeks 7= h]self1 ,mr4 ,murphy ( ,nor? ,c>ol9a1 ,ms4 ,b>ragn1 & ,ms4 ,ku/]7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to direct ! ,secret>y ( ,heal? & ,human ,s]vices to evaluate ! ext5t to :i* ! sub/itution ( int]*angeable biological products may be imp$$ by diff]5ces betwe5 ! sy/em = det]m9+ a biological product to be int]*angeable & ! sy/em = assign+ !rapeutic equival5ce rat+s to drugs1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,biologics ,competition ,act ( #bjbb4 #b4 ,/udy on c]ta9 imp$im5ts to ! sub/itution ( int]*angeable biological products ,n lat] ?an #ab mon?s aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices %all-- 7#a7 complete a /udy to evaluate ! ext5t to :i* ! sub/itution ( int]*angeable biological products lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 may be imp$$ by diff]5ces betwe5 ! sy/em = det]m9+ a biological product to be int]*angeable "u section #cea7k77#d7 ( su* ,act 7#db ,u4,s4,c4 #bfb7k77#d77 & ! sy/em = assign+ !rapeutic equival5ce rat+s to drugs approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 7#b7 submit a report to ! ,congress on ! results ( ! /udy "u p>agraph 7#a72 & 7#c7 update ! li/ publi%$ "u section #cea7k77#i77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#i77;,a77 7commonly ref]r$ to z ! ,purple ,book7 to implem5t su* *anges z ! ,secret>y deems necess>y to h>monize ! approa* = communicat+ ! sub/itutability ( int]*angeable biological products ) ! approa* = communicat+ !rapeutic equival5ce rat+s assign$ to drugs1 ) ! goals (-- 7,a7 m9imiz+ imp$im5ts to ! sub/itution ( int]*angeable biological products2 & 7,b7 ma9ta9+ ! di/9ct pa?ways by :i* biological products are lic5s$ "u section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7 & drugs are approv$ "u section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74