Biosimilar Studies and Comparability Assessments
At Biofidus, we provide biosimilar and comparability assessments that generate robust, regulatory-ready evidence to demonstrate the high similarity, of biosimilars to their reference products.
Our focus on identifying and addressing critical quality attributes (CQAs), ensures that all relevant structural, functional and impurity-related parameters are thoroughly characterized and documented for regulatory review.
Within our analytical biosimilarity support, we combine comprehensive structural and functional characterization of biosimilar and reference products in true head-to-head studies. Using advanced mass spectrometry, chromatographic and physico-chemical methods, we elucidate primary structure, higher-order structure, glycosylation patterns, charge/size variants, and aggregation behavior, while functional comparability is assessed via mechanism-of-action–relevant binding assays (SPR, ELISA), and orthogonal cell-based potency assays. This integrated approach ensures that all CQAs relevant for safety and efficacy are thoroughly understood, controlled and documented for regulatory biosimilarity assessment.
Aligned with ICH Q5E and related ICH quality guidelines, Biofidus offers holistic comparability and biosimilarity assessments that de-risk process changes and biosimilar development. We adapt our platform methods to the properties of your drug substance, its individual formulation matrix, and your specific analytical question, and qualify them as needed according to ICH guidelines.
Strategic biosimilar support for small-molecule pharma
In addition, we support classical small-molecule pharmaceutical companies entering the biosimilar field with market and opportunity evaluations for selected targets, competitor and landscape analyses, and scientific due diligence on biosimilar candidates considered for in-licensing, integrating analytical, technical and regulatory perspectives into a clear and well-founded decision basis.
Get in contact with us to quickly find the optimal setup for your analytical and strategic biosimilar challenges and to speak directly from expert to expert.
