souseikai global clinical research center

Biologics & Biosimilar

SOUSEIKAI has been contributing to Biologic developments in Japan since late 1990s.
Our in-house specialists include Rheumatologists, Hematologists, Diabetes specialists, and a Dermatologist along with 365 experienced staff and 56 physicians have safely conducted over 162 biologics /Follow On Biologics studies at SOUSEIKAI.


Our experience includes;

  • 56 studies of Insulin Preparations
  • 8 studies of Interferons
  • 20 studies of Growth Hormone Preparations
  • 8 studies of GLP1
  • 43 studies of antibody preparations
  • 3 studies of Neurotropic factors
  • 7 studies of G-CSF
  • 13 studies of Erythropoetins
  • 4 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

Publications

J 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.