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sample ha e annual sales unde US$250 mil-li n, p ducts in the t p 15% f sales captu e

ughly tw -thi ds f all the apeutic p teinsales. Se e al f these t p-selling p ductsa e highly c mplex p teins, including anumbe f m n cl nal antib dies. Fu the

bse ati ns f m u analysis include: M e than half f the p tein p ducts

with measu able sales ha e t tal salesunde US$100 milli n.

Twel e bl ckbuste p tein p ducts ha esales g eate than US$1 billi n. These

p ducts c mp ise a c nside able p ti nf the US$39.3 billi n in t tal sales f all

the apeutic p teins. Half f these bl ckbuste d ugs a e

the m st c mplex p tein p ducts(as assessed by m lecula weight).

P tein p ducts app ed as NDAsunde the F d, D ug and C smetic(FD&C) Act a e n a e age less c mplex(as measu ed by m lecula weight) thanth se licensed in BLAs unde the PublicHealth Se ice (PHS) Act.

o e all, just 29 the apeutic p teinp ducts (20 app ed unde BLAs and 9app ed unde NDAs) had annual salesexceeding US$250 milli n, ep esenting e90% f all sales e enues. The c ncent a-ti n f sales f the apeutic p teins am nga small numbe f p ducts is pa ticula ly n tew thy. It suggests that the sa ings tpublic and p i ate paye s that esult f m af ll w- n p tein p ducts p g amme,at least in the sh t te m, may la gely depend

n f ll w- n p duct de el pment f thesefew p ducts.

F eas ns desc ibed in m e detailbel w, f ll w- n p teins a e likely t besignificantly m e c stly t de el p than a esmall-m lecule gene ic d ugs. We the ef eexpect that p duct sales will be an imp tantfact in dete mining which p tein p ductsa e ta geted by f ll w- n de el pe s. Fthe pu p ses f u analysis and discussi n,

we f cus p ima ily n the highest e enuep ducts, which we define as p ducts withannual e enues exceeding US$250 milli n.We d n t exclude the p ssibility that l we

e enue p tein p ducts may als att actf ll w- n e si ns; h we e , we find thatthe US$250 sales e enue th esh ld captu es

e 90% f the t tal sales e enue f p teinp ducts in u data, and s will p bably captu e m st f the p ducts f inte est tf ll w- n de el pe s.

Foc s on ey prod c s and c assesThe dist ibuti n f p tein p ducts by sales and m lecula weight lends itself tfu the g upings f elated p ducts thatha e simila the apeutic use st uctu alsimila ity.FIG. 2 sh ws u suggestedg upings. M st p ducts with salesexceeding US$250 milli n fall int ne f the se en p duct classes: e yth p ietins,g anul cyte-c l ny stimulating fact s(G-CSFs), insulin, inte fe n , humang wth h m ne (hGH, s mat pin),inte fe n and m n cl nal antib dies.We desc ibe b iefly s me f the definingcha acte istics f these se en classes.

Erythropoietins. This class includes th eep tein p ducts that a e am ng th segene ating the highest e enue in 2006,ep etin (Ep gen), ep etin (P c it)and da b p etin (A anesp), a m e

ecently de el ped, l nge -acting agentthan ep etin . These p ducts, whicha e licensed in BLAs unde the PHS Act,stimulate the p ducti n f ed bl d cellsand a e used in the t eatment f anaemiaass ciated with ch nic kidney disease andchem the apy-induced anaemia.

Tabl 1 |S mmary of ey herape ic pro ein prod c s

T a nam P t App alpathwa

N mb f am n a *

App x matMW (da)

Non-glycosylated protein

Fo t o T pa at d NDA 34 4,118

By tta ex nat d NDA 39 4,187

Humalog insul n l sp o NDA 51 5,808Humul n insul n NDA 51 5,808

No ol n insul n NDA 51 5,808

No oLog insul n aspa t NDA 51 5,826

Lantus insul n gla g n NDA 53 6,063

B tas on int f on-1b BLA 165 18,500

N upog n F lg ast m BLA 175 18,800

G not op n Somat op n NDA 191 22,125

Nut op n Somat op n NDA 191 22,125

Glycosylated protein

A on x int f on-1a BLA 166 22,500

r b f int f on-1a BLA 166 22,500

epog n/P o t epo t n BLA 165 30,400

enb l etan pt BLA 934 150,000

A an sp Da b po t n BLA 165 37,000

PEGylated protein

P gint on P g nt f on -2b BLA 165 31,000

N ulasta P gf lg ast m BLA 175 39,000

P gasys P g nt f on -2a BLA 165 60,000

Monoclonal antibody

r tuxan r tux mab BLA 1,328 145,000

H pt n T astuzumab BLA 1,330 146,000

Hum a Adal mumab BLA 1,330 148,000

Synag s Pal zumab BLA 1,320 148,000

A ast n B a zumab BLA 1,320 149,000

Xola Omal zumab BLA 1,324 149,000

r m ad infl x mab BLA 1,308 149,100

e b tux c tux mab BLA 1,326 152,000

Lu nt s ran b zumab BLA 445 48,000*est mat d numb of am no a ds a g n fo mono lonal ant bod s. BLA, b olog s l ns appl at on;MW, mol ula w ght; NDA, n w d ug appl at on.

P e r s P e c t i v e s

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4.5

4.0

3.5

3.0

2.5

2.01.5

1.0

0.5

00 20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000

Approximate molecular weight (daltons)

FD&C Act (n = 25)PHS Act (n = 54)

Aranesp

EpogenProcrit Neulasta

Enbrel

Remicade

Rituxan

Avastin

Herceptin HumiraLantus

Avonex

Granulocyte-colony stimulating factors. This class c nsists f the p ducts filg astim(Neup gen) and pegfilg astim (Neulasta),a l nge -acting PEGylated f m f filg astim.They a e used t t eat neut paenia,a c nditi n cha acte ized by a dec ease inneut phils, a type f white bl d cells thatp tect the b dy against bacte ial infec-ti ns. Neut paenia is a c mm n side effect

f chem the apy t eatments f cance .These p ducts a e als egulated th ughBLAs.

Insulin. rec mbinant insulin p ducts fthe t eatment f diabetes include Humulinand N lin, which a e st uctu ally identi-cal t the insulin p duced by the humanpanc eas, and the m e ecently int -duced insulin anal gues Lantus, Humal g,N L g, Le emi and Apid a. Insulinanal gues a e st uctu ally m dified t alte

thei p pe ties, making them eithe faste - l nge -acting than egula human

insulin. Insulin and insulin anal gues a eegulated th ugh NDAs unde the FD&C

Act.

Interferon . This class includes theinte fe n-1b p duct Betase nand inte fe n-1a p ducts A nex andrebif. These p ducts a e used f thet eatment f multiple scle sis (MS) anda e egulated th ugh BLAs. C pax ne,a synthetic mixtu e f f u amin acids thatis app ed unde an NDA, is als indi-cated f t eatment f MS and c mpeteswith these p ducts.

Interferon . This ma ket is led by twp ducts, peginte fe n -2a (Pegasys) andpeginte fe n -2b (PegInt n), which a eused t t eat ch nic hepatitis C, ften inc mbinati n with iba i in. Standa d inte -fe n p ducts that p eceded these newePEGylated p ducts, r fe n (inte fe n -2a) and Int n-A (inte fe n -2b),a e als ma keted, but a e less f equently p esc ibed f hepatitis C, as studies ha e

sh wn that c mbinati n the apy withPEGinte fe n is m e effecti e than c m-binati n the apy using standa d inte fe n.Standa d inte fe n p ducts a e used f

the indicati ns, including t eatment f ce tain types f cance . Inte fe n p ducts a e egulated th ugh BLAs.

Human growth hormone. This class f ec mbinant p teins includes se e al

s mat pin p ducts, which a e used fa numbe f indicati ns. Gen t pin andN dit pin lead this categ y in sales

and a e used t t eat g wth h m nedeficiencies and a i us c nditi ns ass ci-ated with g wth failu e. othe s mat pinp ducts a e app ed f diffe ent uses,such as Se stim f HIv-ass ciated wasting

cachexia, and Z bti e f the t eatmentf sh t-b wel synd me. These p ducts

a e egulated th ugh NDAs.

Monoclonal antibodies. As a class, m n -cl nal antib dies ha e di e se the apeuticapplicati ns, including cance , heumat ida th itis, ps iasis and asthma. F upu p ses, we c nside m n cl nal anti-b dies as a single class because f theist uctu al simila ity and because they a ec nside ed highly c mplex p teins4.It sh uld be n ted that etane cept(Enb el), ne f the t p-selling the apeuticp teins, is st uctu ally classified as afusi n p tein, but sha es a simila mecha-nism f acti n with the m n cl nal anti-b dy p ducts adalimumab (Humi a) and

infliximab (remicade). All th ee p ductsa e tum u nec sis fact inhibit s,and a e app ed t t eat b th heumat ida th itis and ps iasis.

As sh wn in FIG. 2b , m e than 80% f p tein p duct sales in 2006 we e f mp ducts in these se en classes, making it

eas nable t assume that much f the acti ity we can expect in f ll w- n p tein de el p-ment will ccu in these classes5. It sh uldals be n ted that alth ugh 2006 figu essh w simila sales le els f m n cl nal anti-b dies and e yth p ietin p ducts, sales f

e yth p ietins ha e been declining,whe eas sales f m n cl nal antib dies a ecu ently sh wing apid g wth5.

Pa en expira ions for mar e ed prod c sAlth ugh assessing sales and c mplexity might begin t e eal p ducts that c uldatt act the g eatest inte est f m f ll w- np duct de el pe s, such p ducts can bema keted nly afte patent p tecti n fthe inn at p duct expi es. Dete mininga definite patent expi ati n date f a p -tein p duct can be ext emely difficult,as they a e usually c e ed by multiplepatents, with patents c e ing n t nly thep duct itself but als the manufactu ingp cesses. Expe t pini n diffe s n whence tain p tein p ducts will l se theipatent p tecti n, and unp edictable legaland legislati e e ents c uld influence h wf ll w- n de el pe s na igate th ughthe existing patent landscape 6. We ha ecatal gued inf mati n gathe ed f m

public s u ces, including news and thepublished ep ts, public statements and

ep ts by inn at c mpanies, t esti-mate when ce tain p ducts a e m st likely t l se patent p tecti n. Based n theses u ces, we c nclude that patent p tec-ti n f the la gest-selling b anded p teinp ducts in the US ma ket is unlikely texpi e bef e 2012(FIG. 3) .

only a handful f p tein p ducts a ecu ently ff-patent, and se e al f th sea e app ed in NDAs unde the FD&C Act.o e the next 4 yea s e y few additi nal

F gu 1 |Th ap t p t n p t pla b us al an m l la w ht. Th s f gushows s l t d th ap ut p ot n p odu ts d splay d a o d ng to sal s n th US n 2006 and thmol ula w ght. Th gulato y pathway (Publ H alth S (PHS) A t o Food, D ug & cosm

(FD&c) A t) und wh h a h p odu t was app o d by th US Food and D ug Adm n st at on s alsnd at d. Sou :REF.2


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4/5

b

a

Approved under NDA

Biologicproducts:US$39.3 billion

Total US prescriptiondrug sales 2006:US$274.9 billion

Erythropoietins

Monoclonalantibodies

hGHInsulins

G-CSF

IFN-

IFN-

Other: BLAOther: NDA

2 0 0 6 s a

l e s

( U S

$ b i l l i o n

)

4.5

4.0

3.5

3.0

2.5

2.0

1.5

1.0

0.5

00 20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000

Approximate molecular weight (daltons)

Aranesp

Erythropoietins US$10.1 billion

EpogenProcrit

Fusion protein US$3.1 billion

Remicade

RituxanAvastin

Herceptin Humira

SynagisXolair

Erbitux

Lantus Avonex

IFN- US$2.2 billion

hGH US$1.0 billionFD&C Act (n = 9)PHS Act (n = 20)

Monoclonal antibodies US$10.6 billionG-CSFs US$3.9 billion

IFN- US$0.7 billion

PegIntron PegasysLucentis

Insulins US$4.0 billion

Neupogen

EnbrelNeulasta

p ducts a e expected t c me ff patent.

Alth ugh the e is substantial unce tainty ab ut when indi idual p tein p ducts willl se patent p tecti n, if u assessment f patent expi ati ns h lds t ue, du ing theyea s 20132015, p ducts ep esenting eUS$20 billi n f ma ket alue ughly half f p tein p duct sales in 2006 canbe expected t g ff patent.

Cha enges for fo ow-on prod c sBecause f the c mplex meth ds used tp duce the apeutic p teins, the time andc st equi ed t de el p a f ll w- n p duct

a e expected t be significantly g eate than

f gene ic small-m lecule d ugs. once aefe ence p duct is selected, a f ll w- n

de el pe will need t establish an exp es-si n system that will p duce the f ll w- np duct and de el p a c mme cial scalemanufactu ing p cess that will in l e acl sely m nit ed p cess f pu ificati n,f mulati n and testing f the p duct7.Acc ding t ne estimate, the de el p-ment time f a f ll w- n p tein p ductc uld ange f m 58 yea s c mpa edwith as little as 12 yea s f a gene icsmall-m lecule d ug8,9.

The US F d and D ug Administ ati n(FDA) has ackn wledged that the e a eimp tant diffe ences between p tein d ugp ducts and small-m lecule d ugs, andagency scientists ha e utlined s me f thec mplex scientific challenges facing f ll w-

n p tein p ducts10,11. Cu ent and futu etechnical and scientific ad ances may helpadd ess these challenges, and expe iencegained utside the US in pa ticula , inEu pe, whe e the fi st bi simila p ductsa e beginning t each the ma ket mightals influence de el pment in the US. Still,establishing f ll w- n status t a efe encep tein p duct will p bably be m e c m-plex and time-c nsuming than meeting theapp al standa ds unde the FD&C Act fgene ic small-m lecule d ugs.

Po en ia savings from fo ow-on prod c srecently, se e al published analyses ha e

attempted t estimate the p tential fsa ings t insu e s and the fede al g e n-ment that might be de i ed f m thea ailability f ce tain f ll w- n p teinp ducts. These include analyses by Engeland N itt, Exp ess Sc ipts, A ale e Healthand the C ng essi nal Budget office,which estimate sa ings anging f mUS$3.6 billi n (t the fede al g e nment)t US$71 billi n (t health insu e s) ethe next 10 yea s1215 (BOX 1 , N te 4).This b ad ange f estimates highlightsthe questi n f whe e the ealistic expectedsa ings f a f ll w- n p tein p ductp g amme might fall. Ha ing identifiedthe se en key ma kets in which f ll w- np ducts a e m st likely, we see se e al

eas ns f initial c nse ati e estimates f sa ings in the nea -te m.

re enues f the apeutic p teins a ec ncent ated in a small numbe f b anded p ducts, which suggests alimited numbe f att acti e f ll w- np duct candidates.

r ughly ne qua te f the apeuticp tein sales a e f p ducts in them n cl nal antib dy class, which a e

la ge than m st the the apeuticp teins and a e glyc sylated unlessm dified. The maj ity f m n cl nalantib dy p ducts d n t begin c ming

ff patent until 2015, and a e unlikely tatt act f ll w- n p ducts in the ea ly stages f a f ll w- n e iew p g amme.

The e yth p ietins and G-CSF class f p ducts ha e high sales and m de atep tein size, but a e ep ted t ha e patentp tecti n f thei fi st-gene ati np ducts until at least 2013. B th ma ketsals include a c mpeting l nge -acting

F gu 2 |s l t th ap t p t n p t b p t la . a | S l t d p odu ts w thannual sal s x d ng US$250 m ll on d splay d a o d ng to US sal s and mol ula w ght, andg oup d n s n p odu t lass s. b | Sal s by p odu t lass and as a f a t on of total US p s pt ond ug sal s. BLA, b olog s l ns appl at on; FD&c, Food, D ug and cosm t ; G-cSFs, g anulo-

yt - olony st mulat ng fa to s; hGH, human g owth ho mon ; iFN, nt f on; NDA, n w d ugappl at on; PHS, Publ H alth S . Sou :REF. 2 .


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12

10

8

6

4

2

02007Off-

patent2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

Estimated year of patent expiry

InsulinsErythropoetins

hGHMonoclonal antibodies

IFN-G-CSF

IFN-Other product classes

HumulinNovolin BetaseronNutropin

Genotropin

Enbrel

Epogen/Procrit

Avonex

Remicade

Neulasta

Rituxan

Lantus

Herceptin

Aranesp

HumiraAvastin

PegasysSynagis

PegIntron

NovoLog

Neupogen

HumalogRebif

Byetta

sec nd-gene ati n p duct within theclass (A anesp and Neulasta, especti ely ) that has additi nal yea s f patentp tecti n, which c uld add an additi nalba ie t ent y f a f ll w- n t thefi st-gene ati n p duct.

In the 1980s, s mat pin and insulinwe e am ng the fi st ec mbinant DNAp ducts t be app ed by the FDA, andwe e app ed unde the NDA app alp cess. recently, omnit pe (s ma-t pin) became the fi st ec mbinanthGH p duct t be app ed unde anabb e iated app al pathway 10. Insulinhas simila ly been app ed as an NDA,but has n t yet been app ed unde anabb e iated mechanism. Insulin ana-l gues, which ha e been gaining a sha e

f the diabetes ma ket, a e ep ted tha e 5 m e yea s f patent c e age

emaining. The leading inte fe n p ducts

PegInt n and Pegasys a e ep ted t

ha e patent c e age until 2015. Betase n is the nly app ed BLA with

sales e US$250 milli n that appea st be facing patent expi y in the next5 yea s. H we e , it has fa l we salesthan the newe inte fe n p ductsA nex and rebif, which a e estimatedt ha e patent p tecti n until 2013.C pax ne, which was app ed undethe FD&C Act, is facing patent expi y in2014. If f ll w- n p ducts efe encingC pax ne we e app ed, they c uldc mpete in this ma ket.

S mmaryou analysis sh ws that the sales f the a-peutic p tein p ducts a e c ncent ated ina small numbe f b anded p ducts. Many

f these p ducts a e c mplex p teins thata e ep ted t ha e patent c e age fse e al m e yea s. H we e , if ep tedpatent expi ati n estimates h ld, in the n t-t -distant futu e, a significant numbe f imp tant p tein p ducts with la gecu ent sales will l se patent p tecti n.The maj ity f these p ducts we elicensed unde the PHS Act, which lacksan abb e iated pathway f app al f f ll w- n p ducts, c eating unce tainty fp tential de el pe s f f ll w- n p ducts.

Michael Lanthier, Rachel Behrman and Clark Nardinelli are at the US Food and Dru g

Administration, 5600 Fishers Lane, Rockville,Maryland 20857, USA.

Correspondence to M.L.e-mail: [email protected]

Disclaimer: this article was prepared by the authors

in their private capacities. No official support or endorsement by the US Food and Drug Administration is intended or should be inferred.

doi:10.1038/nrd2636Published online 25 July 2008

1. Express Scripts. Press release 25 April. Biotech DrugSpending Increases 21 Percent Even as Growth in RxExpenditure Slows. Express Scripts web site [online],< http://phx.corporate-ir.net/phoenix.zhtml?c=69641 &p=irol-newsArticle&ID=989907&highlight =>(2007).

2. IMS Health. IMS National Sales Perspectives:Retail and Non-Retail Combined Purchases,JanuaryDecember 2006 (2007).

3. Bhattycharyya, L. et al . Equivalence studies forcomplex active ingredients and dosage forms, matrixof protein types. AAPS J. 7 , e786e812 (2005).

4. Sheridan, C . First generic biologics finally approved. Nature Rev. Drug Discov. 5 , 445 (2006).

5. Aggarwal, S. Whats fueling the biotech engine?Nature Biotech. 25 , 10971104 (2007).

6. Manheim, B. S. Jr, Granahan, P. & Dow, K. J.Follow-on biologics: ensuring continued innovation inthe biotechnology industry. Health Aff. 25 , 394404(2006).

7. Biotechnology Industry Organization (BIO). A Brief Primer on Manufacturing Therapeutic Proteins.BIO web site [online], < http://www.bio.org/healthcare/pmp/factsheet1.asp > (2002).

8. Grabowski, H. G. Statement before Committeeon Oversight and Government Reform (COGR),

United States House of Representatives. COGR website [online],< http://oversight.house.gov/documents/20070416132526.pdf > (2007).

9. Grabowski, H. G., Cockburn, I. & Long, G. The marketfor follow-on biologics: how will it evolve? Health Aff. 25 , 12911301 (2006).

10. Woodcock, J. et al. The FDAs assessment of follow-onprotein products: a historical perspective. Nature Rev.Drug Discov. 6 , 437442 (2007).

11. Woodcock, J. Statement before Committee onOversight and Government Reform (COGR),United States House of Representatives. COGR website [online],< http://oversight.house.gov/documents/20070326104056-22106.pdf > (2007).

12. Engel & Novitt, LLP. Potential Savings That Might BeRealized By the Medicare Program From EnactmentOf Legislation Such As The Access To Life-Saving Medicine Act (H.R.6257/S.4016) That Establishes A New cBLA Pathway For Follow-On Biologics. A ReportTo Pharmaceutical Care Management Association

(PCMA) Based Upon A Preliminary AssessmentOf Available Data. PCMA web site [online],< http://pcmanet.org/assets/2008-03-25_Research_EN%20Paper%20on%20Follow-on%20Biologics%20Jan.%202007.pdf > (2007).

13. Miller, S. & Houts, J. Potential Savings of Biogenericsin The United States. Express Scripts web site [online],< http://www.express-scripts.com/industryresearch/outcomes/onlinepublications/study/potentialSavingsBiogenericsUS.pdf > (2007).

14. Ahlstrom, A., King, R., Brown, R., Glaudemans, J.& Mendelson, D. Modeling Federal Cost Savingsfrom Follow-On Biologics. Alvare Health web site [online], < http://www.avalerehealth.net/research/docs/Modeling_Budgetary_Impact_of_FOBs.pdf > (2007).

15. Congressional Budget Office Cost Estimate. S.1695 Biologics Price Competition and Innovation Actof 2007. CBO website [online], < http://www.cbo.gov/ftpdocs/94xx/doc9496/s1695.pdf > (2008).

F gu 3 |c nt al an t mat pat nt xp f l t p -

t n p t .S l t d th ap ut p ot n p odu ts w th annual sal sx d ng US$250 m ll on d splay d a o d ng to US sal s, st mat d

y a of pat nt xp y and p odu t lass. G-cSF, g anulo yt - olony

st mulat ng fa to ; hGH, human g owth ho mon ; iFN, nt f on.Sou :REF. 2 .


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2009_NRDD_Economic Issues With Follow-On

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