Biosimilars are highly similar to the reference product, with no clinically relevant differences in terms of purity, potency, and safety. And biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. However, biosimilars may be sensitive to tiny changes in manufacturing processes because of their high molecular complexity. Before the animal and clinical trials, biosimilars need to be characterized according to the guidance document ICH Q6B, which provides a uniform set of internationally accepted specifications for the characterization of biological and biotechnological products for approval.
Biosimilar Analysis Solution at Creative Proteomics
Based on years of experience to support the development of biosimilars, Creative Proteomics can provide comprehensive services, including but not limited to:
At Creative Proteomics, we have years of experience of studying for a range of biosimilar molecules and integrated services to support biosimilar development. We also continually develop new methods to support biosimilar characterization and comparability. We are glad to discuss your special requirements and the details of the experiments to provide an optimized and customized analytical support for your comparative characterization of the biosimilar and innovator. If you have any questions or specific requirements, please feel free to contact us.
1. Sorensen M, et al. Comparison of originator and biosimilar therapeutic monoclonal antibodies using comprehensive two-dimensional liquid chromatography coupled with time-of-flight mass spectrometry. mAbs. 2016, 8 (7), 1224-1234.