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PRODUCT INN REFERENCE AUTHORIZATION
Omnitropesomatropin
Genotropin 12/04/2006
Valtropin (W/D) Humatrope 24/04/2006
AbseamedBinocrit
Epoetina alfa hexalepoetin alpha
Eprex28/08/2007
RetacritSilapo
epoetina zeta 18/12/2007
BiograstimFilgrastim
ratiopharm WPRatiograstimTevagrastim filgrastim Neupogen
15/09/2008
Filgrastim HexalZarzio
06/02/2009
Nivestim 08/06/2010
Grastofil 18/10/2013
Ovaleap follitropin alpha Gonal-F 27/09/2013
InflectraRemsima
infliximab Remicade 10/09/2013
follitropin Gonal-F Under review
Insulin glargine Lantus Under review
trastuzumab Herceptin Not submitted yet
1877: A dead heat at the Oxford Vs Cambridge University Boat Race in 1877
Competizione; accesso al mercato; risorse per migliorare
Gare in concorrenza diretta hanno portato ad un abbassamento dei prezzi di oltre il 75% rispetto al periodo precedente la scadenza brevettuale
Overview of currently approved biosimilar products in Europe*
1. EMA. European Public Assessment Reports. Biosimilar Medicines Authorized by the Agency [website]. Accessed Feb 5, 2014; 2. FDA. Information for Consumers – Biosimilars [website]. Accessed Feb 5, 2014
201320102009200820072006
Biograstim®
Ratiograstim®
Tevagrastim®
Omnitrope®
Abseamed®
Binocrit®
Epoetin Alfa Hexal®
Retacrit®
Silapo®
Zarzio® Nivestim®
Inflectra®
Remsima®
Ovaleap®
Filgrastim-Hexal®
Human growth hormone (somatropin)
Erythropoietin (epoetin alfa, zeta)
Granulocyte colony-stimulating factor
Follicule-stimulating hormone (follitropin alfa)
*None FDA-approved as of February 20142
FDA, Food and Drug Administration
Grastofil®
Anti-TNF- monoclonal antibody (infliximab)
PRODUCT INN REFERENCE AUTHORIZATION
Omnitropesomatropin
Genotropin 12/04/2006
Valtropin (W/D) Humatrope 24/04/2006
AbseamedBinocrit
Epoetina alfa hexalepoetin alpha
Eprex28/08/2007
RetacritSilapo
epoetina zeta 18/12/2007
BiograstimFilgrastim
ratiopharm WPRatiograstimTevagrastim filgrastim Neupogen
15/09/2008
Filgrastim HexalZarzio
06/02/2009
Nivestim 08/06/2010
Grastofil 18/10/2013
Ovaleap follitropin alpha Gonal-F 27/09/2013
InflectraRemsima
infliximab Remicade 10/09/2013
follitropin Gonal-F Under review
Insulin glargine Lantus Under review
trastuzumab Herceptin Not submitted yet
Remicade: ATTRACT1 CT-P13: PLANETRA2
1O Endpoint Results
EfficacyACR20 at wk 30 (PP)ACR20 at wk 30 (ITT)ACR20 at wk 54Mean change from baseline (vdH-S Total)
Pbo +
MTX
--20%17%6.9
R® 3
mg/kg
(q8wk)
--50%42%1.3
R® 10
mg/kg
(q8wk)
--52%59%0.2
CT-P13
60.9%73.4%----
IFX 3 mg
58.6%69.7%----
2O Endpoint Results
EfficacyACR50 at wk 30ACR70 at wk 30
5%0%
27% 8%
31% 18%
42.3% 20.2%
40.6% 17.9%
Adverse Events
SafetyStudy-Related AEsRelated infection>=1 Infusion reactionTuberculosisSerious adverse eventsSerious infectionsSerious infusion reactionsAntinuclear antibodiesAntibodies against doublestranded DNA
-- -- -- -- 21% 8% 0% 26% 0%
-- -- -- -- 11% 2% 0% 68% 10%
-- -- -- -- 20% 8% 0% 62% 10%
35.2% 15.3% 5% 3 pts -- -- -- -- --
35.9% 16.9% 6% 1 pt -- -- -- -- --
1. Remicade: Label Full Prescribing Information, P3 Trial (NCT00269867), Journal Article Lipsky et al, 2000. N Engl J Med. 2000 Nov 30;343(22):1594-6022. CT-P13: PLANETRA P3 Trial (NCT01217086), Abstract 1: EULAR12-2238, Abstract 2: EULAR12-2547……..P’Kinetic data for CT-P13 is reported for patients with ankylosing spondylitis
INDICAZIONI: rheumatoid arthritis, adult Crohn’s disease, paediatric Crohn’s disease,
ulcerative colitis, paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis
and psoriasis
Gonal-F Ovaleap
patients 145 152
Number of oocytes retrievedprimary endpoint
12.0 + 6.8 12.2 + 6.2
Total dose (S.E.) 1614 + 484 1539 + 495
# pts with dose increase 43.2% 35.9%
# patients with dose decreases
15.1% 15.0%
Ongoing pregnancy rate 0.34 0.28
Lo studio del biosimilare FSHSetting: Infertile ovulatory women undergoing ART
PRODUCT INN REFERENCE AUTHORIZATION
Omnitropesomatropin
Genotropin 12/04/2006
Valtropin (W/D) Humatrope 24/04/2006
AbseamedBinocrit
Epoetina alfa hexalepoetin alpha
Eprex28/08/2007
RetacritSilapo
epoetina zeta 18/12/2007
BiograstimFilgrastim
ratiopharm WPRatiograstimTevagrastim filgrastim Neupogen
15/09/2008
Filgrastim HexalZarzio
06/02/2009
Nivestim 08/06/2010
Grastofil 18/10/2013
Ovaleap follitropin alpha Gonal-F 27/09/2013
InflectraRemsima
infliximab Remicade 10/09/2013
follitropin Gonal-F Under review
Insulin glargine Lantus Under review
trastuzumab Herceptin Not submitted yet
Primi 20 principi attivi per consumo(a valore)
Ran
k Consumi a valore 2013(Migliaia di€)
Variazioni %2013 vs 2012
Quota di mercato
ITALIA 8.585.043 5,3% 100,0%
→ TRASTUZUMAB 232.484 -0,4% 2,7%
↑ ETANERCEPT 214.272 3,2% 2,5%
↑ ADALIMUMAB 212.804 12,1% 2,5%
→ EPOETINA ALFA 180.113 -0,2% 2,1%
↑ INTERFERONE BETA 1A 178.984 3,3% 2,1%
↑ IMMUNOGLOBULINA UMANA NORMALE 177.906 4,8% 2,1%
→ RITUXIMAB 174.078 1,0% 2,0%
↓ IMATINIB MESILATO 159.812 -1,3% 1,9%
→ OCTOCOG ALFA (FATTORE VII COAGULAZ) 135.226 -0,2% 1,6%
↑ BEVACIZUMAB 133.856 4,7% 1,6%
↓ EMTRICITABINA TENOFOVIR DISOPROXIL 128.795 -1,1% 1,5%
↑ LENALIDOMIDE 124.082 6,5% 1,4%
↑ EFAVIRENZ EMTRICITABINA TENOFOVIR DI 108.511 2,3% 1,3%
↑ RANIBIZUMAB 106.675 85,7% 1,2%
↑ INFLIXIMAB 103.859 1,1% 1,2%
→ PEMETREXED DISODICO 89.940 -0,5% 1,0%
↓ ALBUMINA UMANA 84.048 -7,4% 1,0%
↑ ENOXAPARINA SODICA 83.720 10,7% 1,0%
↑ PACLITAXEL 83.215 6,4% 1,0%
↑ BORTEZOMIB 78.358 5,9% 0,9%
TOTALE PRIMI 20 2.790.738 4,4% 32,5%
TOTALE ALTRI 5.794.305 5,7% 67,5%
Ongoing phase III trials with Anti-HER2 ABs
• Adjuvant:
- Pertuzumab + Trastuzumab vs Trastuzumab (Aphinity)
- Trastuzumab Emtansine vs Trastuzumab + Pertuzumab (Kaitlin)
- Trastuzumab Emtansine vs Trastuzumab (no pCR after neoadjuvant therapy) (Katherine)
• Neo/adjuvant:
- Taxane + Pertuzumab + Trastuzumab vs Trastuzumab Emtansine + Pertuzumab (Kristine)
• Advanced:
- 1° line: Trastuzumab + Taxane vs Trastuzumab Emtansine vs Trastuzumab Emtansine + Pertuzumab (Marianne)
- 2°line: Pertuzumab + TPC vs TPC (Traetment of Phisician Choice)