Testing Solutions For Biosimilars

A Biosimilar is a highly similar version of an FDA-approved biologic, offering cost-effective alternatives for conditions like cancer and rheumatoid arthritis. Regulatory agencies mandate comprehensive analytical comparisons between biosimilars and reference products to demonstrate similarity.

SGS, with extensive experience in analytical testing for biologics, helps navigate these requirements, conducting thorough comparative assessments. Our scientists offer insights into physicochemical and structural properties, including post-translational modifications, through a range of assays. We also develop and validate test methods for characterization, comparability studies, and routine testing to support biosimilar development and commercialization.

Our support includes comparing reference and biosimilar products using recommended test methods on carefully selected lots to account for manufacturing variability and product degradation. Learn more by downloading our datasheet below.