PRODUCT INN REFERENCE AUTHORIZATION Omnitrope … · Lo studio del biosimilare FSH ... PRODUCT INN REFERENCE AUTHORIZATION Omnitrope somatropin Genotropin 12/04/2006 Valtropin (W/D)
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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
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