FDA has accepted for review the biologics license application for FYB206, a proposed pembrolizumab biosimilar developed without a comparative phase 3 efficacy trial. A decision could come in the third quarter of 2027.
|Articles|August 15, 2014
- BioPharm International-08-15-2014
- Volume 2014 eBook
- Issue 2
Testing the Quality, Safety, and Efficacy of Insulin Biosimilars
Development and validation of two pivotal assays for in-vitro comparability testing of insulin biosimilars.
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Development and validation of two pivotal assays for in-vitro comparability testing of insulin biosimilars.
from BioPharm International’s 2014 Analytical and Bioanalytical eBook.
Articles in this issue
about 12 years ago
Keys to Successful Method Transferabout 12 years ago
The Challenge of Finding the Unknownabout 12 years ago
Using the Purity Quotient Difference to Assess Protein Purificationabout 12 years ago
Standardizing Data ManagementAdvertisement
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