HIGHLIGHTS
- who: Saima Sadaf from the Biopharmaceutical and Biomarkers Discovery Laboratory, School of Biochemistry and Biotechnology, University of the have published the paper: Biosimilars: A Comparative Study of Regulatory, Safety and, in the Journal: (JOURNAL) of June/10,/2020
- future: If structure and function studies data_analysis lead to higher uncertainty additional clinical studies (such as comparative PK and PD followed by safety/immunogenicity and efficacy studies) may be required for the biosimilar product to get DRAP`s approval. If difference in mechanism-of-action are taken as relevant additional studies (nonclinical or clinical) may be needed . . .
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