Biosimilars
Smooth Drug Development provides services for full registration programs of generic biotechnology drugs (biogenerics or biosimilars).
To register a biosimilar product, within the registration dossier it is necessary to provide producer`s own data on pre-clinical and clinical studies.
Clinical studies are conducted in two stages:
- A safety study. Such studies are conducted as phase I studies in healthy subjects, or in patients depending on the product safety profile.
- An efficacy study. Such studies are conducted as phase III studies.
We are fully aware of all the difficulties that might occur during pre-clinical studies, study design preparation, clinical studies, and drug registration.
We have performed clinical trials with biosimilars in anemia, multiple sclerosis, viral hepatitis, as well as in oncology and rheumatology.