biosimilars

A challenge for clinical research studies

CRS is highly experienced in the clinical development of biosimilars

Bioanalytics Biosimilars CRS Group

Developing a biosimilar product simply requires to prove the high similarity of the biosimilar to the original biologic product and that it will accomplish the same therapeutic and clinical effects. However, anything but simple is the complex and multicomponent comparability exercise for this proof. Part of this exercise is the conduct of clinical research studies in humans.

These comparative studies involve unique challenges. One is the enrolment of large cohorts of volunteers and patients committed to participate in such studies with many ambulatory visits during long follow-up periods. This challenge is not typically found in other types of Early Phase studies.

CRS knows and understands these challenges as its experts have accumulated more than 15 years of experience in the development of biologics, in particular in the field of biosimilars.

CRS’ units, which are located in metropolitan areas, guarantee fast and reliable access to those volunteers and patients that meet these particularities.