Expertise

Biosimilar Insulins

CCDRD AG completed two independent biosimilar insulin developments with pivotal immunogenicity, CLAMP, therapeutic equivalence and safety trials. The insulin types were rapid insulin, NPH insulin as well as a mix of both types.

Two clinical developments – 6 phase III trials

Therapeutic equivalence of recombinant human insulin, multicentric

250 type I diabetes patients

Therapeutic equivalence of recombinant human insulin, multicentric

300 type II diabetes patients

Open follow-up safety study, monocentric

200 type I diabetes patients

Open follow-up safety study, multicentric

210 type II diabetes patients

Immunogenicity study comparing two insulins, multicentric

500 patients

Comparison of PD and PK parameters using CLAMP technique, monocentric

24 diabetes patients

Immunogenicity study of two recombinant insulins, multicentric

500 patients