Generic and originator immunosuppressants - comparative list prices and bioequivalence data
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1 Ciclosporin Neoral (Novartis) Capimune (Mylan) NHS Net price (as per the BNF) Date: November 2016 Bioequivalence assessment vs. originator 10mg capsule, 60= mg capsule, 30= mg capsule, 30= mg capsule, 30= mg/ml oral soln, 50ml= n/a 25mg cap, 30= mg, 30= mg, 30= PL 04569/ PL 04569/ Study design Fasting/ fed state? Mean ratios of test product to originator and 90% CIs - from public domain data Subjects in final assessment: n= Cmax AUC study of 2 x 100mg Capimune versus 2 x 100mg Neoral Fasting (94-104%) 99 (96-103%) study of 2 x 100mg Capimune versus 2 x 100mg Neoral Fed (88-123%) 97 (88-108%)
2 Capsorin (Morningside) Deximune (Dexcel) 25mg cap, 30= 13.05, 50 mg cap, 30= 25.59, 100mg cap, 30= PL 20117/ PL 20117/ mg cap, 30= mg, 30= mg, 30= PL 14017/ Randomised, two-way, crossover study of 2 x 100mg Capsorin versus 2 x 100mg Neoral Fasting? Not stated 99 (94-104%) 99 (96-103%) Randomised, two-way, crossover study of 2 x 100mg Capsorin versus 2 x 100mg Neoral Fed? Not stated 104 (88-123%) 97 (88-108%) study of 2 x 100mg Deximune versus 2 x 100mg Neoral Fasting (90-109%) 101 (93-109%) Vanquoral (Teva) 10 mg cap,60= mg cap, 30= 13.05, 50mg cap, 30= 25.59, 100mg cap,30= PL 14017/ PL 00289/ study of 2 x 100mg Deximune versus 2 x 100mg Neoral Fed - standard high-fat highcalorie breakfast ( %) 106 ( %) Randomised, single-dose crossover study of 100mg Vanquoral versus 100mg Sandimmun Optoral (German Neoral) Fasting ( %) 102 (99-104%)
3 PL 00289/ Randomised, single-dose crossover study of 100mg Vanquoral versus 100mg Sandimmun Optoral (German Neoral) Fed - high fat high calorie breakfast (97-108%) 102 ( %) Tacrolimus Prograf (Astellas) Advagraf (SR, Astellas) Modigraf (Granules, Astellas) Envarsus (m/r, Chiesi) 50= mg, 50= 80.28; 100= = n/a 50= mg, 50= 71.59; 100= mg, 50= = n/a 0.2 mg sachet, 50= mg, 50= n/a 0.75mg tab, 30= 44.33; 1mg, 30= mg, 30= n/a strictly as Envarsus is not a generic as such but is similar to an originator medicine. It contains tacrolimus but has been formulated in a different way and at different doses to its reference product Advagraf. Approved as having comparable quality, safety and efficacy as Advagraf and Prograf, based on clinical data.
4 Adoport (Sandoz) Capexion (Mylan) Tacni (TEVA) Vivadex (Dexcel) 50= 42.92; 1mg, 50= 55.69, 100= = PL 04416/ = mg, 50= 68.20; 100= = PL 23022/ = mg, 50= 65.49; 100= = PL 00289/ = mg, 50= 60.21; 100= = PL 14017/ Open label, single dose, two-way crossover PK assessment of Adoport versus Prograf Fasting 42 (5mg) 207 (0.5mg) 5mg (92-111%). 0.5mg (94-111%) 5mg (99-110%). 0.5mg ( %) Randomised, two treatment, two-period, single dose crossover PK assessment of 5mg Capexion versus 5mg Prograf Fasting ( %) 99 (93-105%) Randomised, two treatment, two period, single dose crossover PK assessment of 5mg Tacni versus 5mg Prograf Fasting ( %) 99 (93-105%) Randomised, two treatment, two-period, single dose crossover PK assessment of 5mg Vivadex versus 5mg Prograf Fasting ( %) 99 (93-105%)
5 Mycophenolate mofetil CellCept (Roche) Arzip (Winthrop/ Zentiva) 250mg cap, 100= mg capshaped tab, 50= g per 5ml powder for oral susp, 175ml= n/a All nonproprietary forms stated as: 250mg cap 100= 82.26; 500mg tab 50= PL 17780/0301 Open label, randomised, twotreatment, two period, two sequence crossover PK assessment of 500mg Arzip versus CellCept Fasting (96-118%) 99 (96-102%) Myfenax (TEVA) All nonproprietary forms stated as: 250mg cap 100= 82.26; 500mg tab 50= EU/1/07/438/003_5 EU/1/07/438/001_2 EU/1/07/438/006 Open label, single dose, two period, two sequence studies. Assessment of 250 mg Myfenax capsules and 500 mg tablets in both fasting and fed states versus CellCept. Fasting and Fed 78 (250mg fasting), 38 (250mg fed), 77 (500mg fasting), 112 (500mg fed) 96 (89-103%), 95 (86-106%), 99 (87-113%), 94 (87-102%) respectively 102 ( %), 104 (99-108%), 98 (95-102%), 101 (98-103%) respectively
6 Also unbranded versions from Mylan, Sandoz, Dr. Reddy, Accord, Waymade, Cubic, AAH, Sigma, Actavis, Colorama, JMMcGill, Phoenix, Wockhardt All nonproprietary forms stated as: 250mg cap 100= 82.26; 500mg tab 50= 82.26
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