Comparative stability study and aggregate analysis of Bevacizumab marketed formulations using advanced analytical techniques.

ABSTRACT: Bevacizumab (Bvz) is the most preferred recombinant humanized monoclonal antibody in biosimilar development due to its prominence as a standard treatment in the oncology space. Therapeutic monoclonal antibodies are typically more complex and unlikely to produce a replica. As a result, regulatory agencies allow approval of biosimilars that differ structurally and functionally from their reference product, but these differences should not have any clinical significance. To identify these significant discrepancies, it is essential to perform a thorough characterization of critical product attributes both in real-time and after storage until the product's expiration. In the present study, two Bvz biosimilar brands (Bio-1 and Bio-2) marketed in India were evaluated and compared with the referen

SUBMITTER: Bana AA 

PROVIDER: S-EPMC10558615 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature