,,ii ,cal5d> ,no4 #ebj #aai? ,,congress #b;d ,session ,s4 #adad ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,april #aj1 #bjbe,mr4 ,paul 7= himself1 ,mr4 ,lee1 & ,ms4 ,hassan7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,july #bg1 #bjbf,report$ by ,mr4 ,cassidy1 ) an amendment,strike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,a ,,bill ,to am5d ! ,public ,heal? ,s]vice ,act to provide t cl9ical /udies requir$ = lic5sure ( biological products z biosimil> %all n be requir$ to include ! assessm5t ( immunog5icity1 ph>macodynamics1 or comp>ative cl9ical efficacy4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,exp$it$ ,access to ,biosimil>s ,act4 #b4 ,assessm5t ( immunog5icity1 ph>macodynamics1 or comp>ative cl9ical efficacy 9 cl9ical /udies requir$ = lic5sure ( biological products z biosimil> 7a7 ,9 g5]al ,section #cea7k77#b77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77 is am5d$-- 7#a7 9 clause 7i77,i7-- 7,a7 9 item 7bb71 by /rik+ & at ! end2 & 7,b7 by /rik+ item 7cc7 & ins]t+ ! foll[+ 7cc7 a cl9ical /udy or /udies assess+ ph>macok9etics t are suffici5t to demon/rate safety1 purity1 & pot5cy2 & 7dd7 subject to clause 7iv71 a cl9ical /udy or /udies t are suffici5t to demon/rate safety1 purity1 & pot5cy 9 #a or m appropriate conditions ( use = :i* ! ref]5ce product is lic5s$ & int5d$ to be us$ & = :i* lic5sure is s\ght = ! biological product2 2 & 7#b7 by add+ at ! end ! foll[+3 7iv7 ,cl9ical /udies 7,i7 ,9 g5]al ,subject to subclause 7,,ii71 ! ,secret>y may det]m9e1 9 ! ,secret>y's discretion1 t a cl9ical /udy requir$ "u clause 7i77,i77dd7 %all include ! assessm5t ( immunog5icity1 ph>macodynamics1 or comp>ative cl9ical efficacy4 7,,ii7 ,requirem5t ,! ,secret>y may only require ! assessm5t ( immunog5icity1 ph>macodynamics1 or comp>ative cl9ical efficacy pursuant to a det]m9ation "u subclause 7,i7 if ! ,secret>y provides to ! applicant notice ( ! requirem5t1 includ+ a writt5 ju/ification ( ! basis = su* det]m9ation1 n lat] ?an ! e>lie/ date on :i* ! applicant may file ! application "u ?is subsection4 4 7b7 ,applicability ,! am5dm5ts made by subsection 7a7 %all apply ) respect to an application submitt$ "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 on or aft] ! date ( enactm5t ( ?is ,act4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,exp$it$ ,access to ,biosimil>s ,act4 #b4 ,data requir$ = lic5sure ( biological products z biosimil> 7a7 ,9 g5]al ,section #cea7k77#b77;,a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77 is am5d$-- 7#a7 9 clause 7i77,i7-- 7,a7 9 item 7bb7-- 7i7 by /rik+ or 7cc7 & ins]t+ 1 7cc71 or 7dd72 & 7ii7 by /rik+ & at ! end2 & 7,b7 by /rik+ item 7cc7 & ins]t+ ! foll[+ 7cc7 an assessm5t ( ph>macok9etics & immunog5icity 7:i* may rely on1 or consi/ (1 a cl9ical ph>macok9etics /udy or /udies describ$ 9 item 7aa7 or 7dd771 z appropriate2 & 7dd7 a cl9ical /udy or /udies1 if requir$ by ! ,secret>y pursuant to clause 7ii77,,ii71 to support a demon/ration t !re is no cl9ically mean+ful diff]5ce betwe5 ! biological product & ! ref]5ce product 9 t]ms ( safety1 purity1 & pot5cy ( su* product2 2 & 7#b7 9 clause 7ii7-- 7,a7 9 ! clause head+1 by /rik+ ,det]m9ation & ins]t+ ,det]m9ations2 7,b7 by /rik+ ,! ,secret>y may & ins]t+ ! foll[+3 7,i7 ,9 g5]al ,! ,secret>y may 2 & 7,c7 by add+ at ! end ! foll[+3 7,,ii7 ,proc$ure = c]ta9 /udies 7aa7 ,9 g5]al ,= an application = lic5sure ( a biosimil> biological product submitt$ "u ?is subsection1 ! ,secret>y may require a cl9ical /udy t includes an assessm5t ( ph>macodynamics or efficacy1 z describ$ 9 clause 7i77,i77dd71 only if ! ,secret>y provides a writt5 det]m9ation1 z describ$ 9 item 7bb7 or 7cc71 to ! sponsor ( ! biosimil> biological product t su* assessm5ts or /udies are necess>y1 9 comb9ation ) o!r in=mation requir$ pursuant to clause 7i77,i71 to demon/rate biosimil>ity4 7bb7 ,writt5 det]m9ation ,! ,secret>y %all-- 7,,aa7 :5 ! ,secret>y issues meet+ m9utes ( a biosimil> biological product developm5t meet+ 7z su* t]m is def9$ 9 section #gdd;,g7#e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act71 provide a writt5 det]m9ation describ$ 9 item 7aa71 or provide writt5 notice to ! sponsor t describes :y su* a det]m9ation c n be made at su* "t2 & 7,,bb7 if ! ,secret>y is unable to make a writt5 det]m9ation describ$ 9 item 7aa7 at ! "t describ$ 9 subitem 7,,aa71 provide su* det]m9ation n lat] ?an #fj days aft] ! date ( submission ( an application = lic5sure "u ?is section4 7cc7 ,am5dm5t to a det]m9ation ,a writt5 det]m9ation "u ?is subclause %all n be am5d$ to require a cl9ical /udy or /udies describ$ 9 clause 7i77,i77dd7 aft] ! date on :i* su* a det]m9ation is made1 except-- 7,,aa7 by writt5 agreem5t ) ! sponsor2 or 7,,bb7 9 ! case t ! ,secret>y det]m9es !re is a sci5tific ju/ification to am5d ! det]m9ation1 provides a detail$ writt5 ju/ification to ! sponsor z soon z practicable1 &1 ^u ! reque/ ( ! sponsor1 holds a biosimil> biological product developm5t meet+ 7z su* t]m is def9$ 9 section #gdd;,g7#e7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act7 to discuss ! am5dm5t4 4 7b7 ,/reaml9+ biosimil> reviews ,section #cea7k77#e7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77#e77 is am5d$-- 7#a7 by /rik+ subp>agraph 7,b72 & 7#b7 by r$esignat+ subp>agraph 7,c7 z subp>agraph 7,b74 7c7 ,applicability ,! am5dm5ts made by subsections 7a7 & 7b7 %all apply ) respect to an application submitt$ "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k77 on or aft] ! date ( enactm5t ( ?is ,act4 ,july #bg1 #bjbf,report$ ) an am5dm5t