Biologics & Biosimilar
SOUSEIKAI has been contributing to Biologic developments in Japan since late 1990s.
Our in-house specialists including Rheumatologists, Hematologists, Diabetes specialists, and a Dermatologist along with 270 experienced staff and 50 physicians have safely conducted over 189 biologics /Follow On Biologics studies at SOUSEIKAI.
Our experience includes;
- 59 studies of Insulin Preparations
- 8 studies of Interferons
- 20 studies of Growth Hormone Preparations
- 8 studies of GLP1
- 57 studies of antibody preparations
- 3 studies of Neurotropic factors
- 7 studies of G-CSF
- 20 studies of Erythropoetins
- 1 study of GIP Recepter Agonist
- 6 studies of metabolic drugs
- 60-130 subjects enrolled for each Biosimilar Studies
Study experience includes:
- Patient Subjects
- Caucasian Studies
- Comparison Studies (Fomulations, doses, administration route)
- Over 6 months of Investigational site visits
For Japanese regulatory perspectives, please check here;
Here are some of related publications from the PMDA
PublicationsJ Biopharm Stat. 2014;24(6):1165-72. doi: 10.1080/10543406.2014.941983.
Clinical development and trial design of biosimilar products: a Japanese perspective.
Biologicals. 2011 Sep;39(5):328-32. doi: 10.1016/j.biologicals.2011.06.015. Epub 2011 Sep 3.
Quality, safety and efficacy of follow-on biologics in Japan.