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

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.