One filgrastim biosimilar, EP2006 (Zarzio®; Sandoz GmbH, Kundl, Austria), was approved in Europe in 2009 for the same indications as those of its reference product, on the basis of extensive protein characterization and clinical studies in healthy volunteers and patients with breast cancer, which confirmed its similarity to the EU-approved originator product [ 1, 2].
An active control (ibuprofen 400 mg, as an acid formulation) was included in order to demonstrate the sensitivity of the pain model, because it was significantly superior to placebo in trials in the same indication [18 20], and has the largest body of data for the indication [3].
The intention being to allow comparison of the effect of treatments in the same indication but whilst using different instruments.
In 2000 in the European Union, fifty per cent or more of medicines used in children have never been studied in this population, but only in adults, and not necessarily in the same indication (or the same disease) [ 2].
Paclitaxel, the other available taxane, has also demonstrated potential activity in the same indication in a few phase II studies (Socinski et al, 1999; Juan et al, 2002; Socinski et al, 2002; Sculier et al, 2002a; Buccheri and Ferrigno, 2004; Ceresoli et al, 2004; Yasuda et al, 2004).
The short duration in this study in which patients may not receive established antimanic medication of 4.5 days at maximum (screening + treatment period), being shorter than usual wash-out or placebo run in-periods of 7 days in other studies in the same indication [ 50, 51], justifies the treatment with placebo in the half of the patients.
With this in mind, it is interesting to note that one of the main observations of Messori and colleagues' survey (n = 56 for sepsis) is at variance with the results from a very much larger RCT reported in the same indication by Warren and colleagues (n = 2341 for sepsis) [ 5].
Patients with a history of trauma in the 6 months prior to treatment, a surgical intervention for the same indications in the previous year, synovitis, high-grade osteoarthritis (grade 4 Kellgren), axial defects >10°, systemic malignancies, metabolic disorders, and BMI > 40 were excluded from the analysis.
Stents have been used in the benign setting with the same indications.
To assess endothelial cell density (ECD) and model 10-year cell loss after Descemet stripping endothelial keratoplasty (DSEK), and to compare with results after penetrating keratoplasty (PK) performed for the same indications in the Cornea Donor Study CDSS).
