Expertise

Biosimilar Erythropoetin

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