FDA released "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)". It sets forth revisions to the 2021 3rd revision and 'recommends reducing unnecessary clinical pharmacokinetic (PK) testing when scientifically justified-potentially saving developers ~$20M (up to 50% of PK study costs) and helping lower drug costs for patients.' The devil will be in the details of what constitutes 'scientifically justified'.
FDA Takes Further Steps to Streamline Biosimilar Development and Make Medicines More Affordable
| U.S. Food and Drug Administration |
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| FDA Takes Further Steps to Streamline Biosimilar Development and Make Medicines More Affordable |
| The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like "generic" versions of biologic drugs. |
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#fda #Biosimilar
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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