CCDRD pioneered in the development of biotechnology drugs with the clinical development of biosimilar Erythropoetin (EPO). The pivotal clinical programs for two application routes resulted in marketing authorization of the drug under the brand names Retacrit®/Silapo® in 2007.
Clinical development consisted of strategic planning, scientific advice procedures with the European Medical Agency (EMA) and the conduct of nine separate, multicentric, multinational clinical studies in 100 healthy subjects and a total number of 1800 renal disease and oncology patients.
5 Phase III trials, multicentric, multinational
Therapeutic equivalence of subcutaneous and intravenous administration of Epoetin
490 patients
Safety and efficacy study for treatment of renal anemia
350 patients
Therapeutic equivalence for maintenance treatment of renal anemia
340 patients
Therapeutic equivalence in correction phase of renal anemia
400 patients
Therapeutic efficacy in oncology patients
200 patients
4 Phase I trials, monocentric
Pharmacokinetic study
24 healthy volunteers
Pharmacokinetic study
12 healthy volunteers
Pharmacokinetic study
48 healthy volunteers
Single dose kinetics i.v.
24 healthy volunteers