Biosimilar is a biomedical product produced by another company, which is almost the same duplicate of the original and created after the patent protection for original biopharmaceutical products expired. Its characteristic is very similar to the original drug in structure, quality, considerable bioactivities and bioequivalence. Biosimilars have become a global concern for a number of reasons. For example, safety, purity and efficacy of biosimilars offer similar benefits to reference biological products; drugs represented by monoclonal antibodies and recombinant protein drugs have developed rapidly in recent years; many original biopharmaceutical products have entered the intermediate stage, etc. Protein biosimilars are developed after the patent of biological drugs expires. The more patents expire, the more room for the development of protein biosimilars. So, it is necessary to understand protein biosimilars’ structure and biological characteristics.
What Is Protein Biosimilar?
Protein biosimilar is a protein-based drug, which is one of the most important biosimilars. Protein biosimilars are also formed by transcription, translation and processing of genes, and have high molecular weight, complex three-dimensional structure, heterogeneity and biological activity, just like original protein drugs. The molecular mass is usually between 18,000 and 145,000. The active component of protein biosimilars is not a single molecule, but a collection of macromolecular protein isomers. Their heterogeneity is reflected in the fact that even under the same expression vector, technology and production process. The same protein biosimilars produced by different manufacturers are more or less different from each other. Biological activity is shown to have effects like original protein drugs, which plays a corresponding role in the body. But this is different from original protein drugs, because protein structures change easily, and even small changes can affect their activity. In addition, for bioequivalence, protein biosimilars are different from original biosimilars. Therefore, the analysis of biosimilars is important.
Characterization of Protein Biosimilar at Creative Proteomics
At Creative Proteomics, we provide information on protein biosimilars, including the structure of protein biosimilars, the physicochemical properties of protein biosimilars, the impurities associated with the production of protein biosimilars.
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1. Capgemini Consulting. Origins and future of the biosimilars industry. DVFA Life Science Conference. Frankfurt, 2010-06-08.
2. Crommelin DJ, Bermejo T; et al. Pharmaceutical evaluation of biosimilars：important differences from generic low-Molecular weight pharm．Eur J Hosp Pharm Sci, 2005,11(1):11-17．