We deliver robust characterization solutions for biosimilars and biobetters with our side-by-side assay panels, Fc-effector function testing, and iLite® bioassays.
Biosimilar and Biobetter Characterization
Example Applications
FAQ
What is biosimilarity assessment?
Biosimilarity assessment evaluates whether a biosimilar demonstrates a high degree of similarity to an approved reference product.
What factors are compared during biosimilar assessment?
Analytical characteristics, biological activity, potency, binding properties, and functional performance are commonly evaluated.
Why are functional assays important in biosimilar development?
Functional assays help demonstrate that the biological activity of a biosimilar is comparable to the reference product.
What is a biobetter?
A biobetter is a biologic designed to provide improved performance, efficacy, dosing, or safety compared with an existing biologic therapy.
What is the difference between a biosimilar and a biobetter?
A biosimilar is developed to be highly similar to an approved reference biologic, while a biobetter is designed to improve certain properties such as efficacy, safety, dosing frequency, or stability.
How can Svar support biosimilar and biobetter characterization?
Svar Life Science supports biosimilar and biobetter development through bioanalytical testing, potency assays, cell-based assays, biomarker expertise, and characterization services designed to support development and regulatory requirements.
