The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of Biosimilars
The US FDA’s new guideline suggests using “Generally Accepted Science Knowledge” (GASK) to develop nonclinical testing protocols for developing drugs and biologicals to remove unnecessary testing. Interpreting acceptable scientific knowledge as a rational approach has motivated the author to suggest...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-10-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/16/11/1517 |
| _version_ | 1797458109816373248 |
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| author | Sarfaraz K. Niazi |
| author_facet | Sarfaraz K. Niazi |
| author_sort | Sarfaraz K. Niazi |
| collection | DOAJ |
| description | The US FDA’s new guideline suggests using “Generally Accepted Science Knowledge” (GASK) to develop nonclinical testing protocols for developing drugs and biologicals to remove unnecessary testing. Interpreting acceptable scientific knowledge as a rational approach has motivated the author to suggest substantial changes to the development of biosimilars, as demonstrated in this paper. The FDA can accept these suggestions without requiring any legislative change to the Act that defines such requirements. Suggested here is the waiving of clinical efficacy testing due to its lower sensitivity compared to analytical and functional testing and pharmacokinetic profiling. Also questioned is the need to test pharmacodynamic markers that do not correlate with clinical response and find new biomarkers requiring extensive testing to validate their use. Should the FDA accept these scientifically rational suggestions, it will significantly reduce the time and cost of approving biosimilars without safety or efficacy risk, as justified based on acceptable scientific knowledge and rationality. |
| first_indexed | 2024-03-09T16:32:23Z |
| format | Article |
| id | doaj.art-7fead38276bf458093b35a2b1051e80f |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-09T16:32:23Z |
| publishDate | 2023-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-7fead38276bf458093b35a2b1051e80f2023-11-24T15:00:01ZengMDPI AGPharmaceuticals1424-82472023-10-011611151710.3390/ph16111517The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of BiosimilarsSarfaraz K. Niazi0College of Pharmacy, University of Illinois, Chicago, IL 60612, USAThe US FDA’s new guideline suggests using “Generally Accepted Science Knowledge” (GASK) to develop nonclinical testing protocols for developing drugs and biologicals to remove unnecessary testing. Interpreting acceptable scientific knowledge as a rational approach has motivated the author to suggest substantial changes to the development of biosimilars, as demonstrated in this paper. The FDA can accept these suggestions without requiring any legislative change to the Act that defines such requirements. Suggested here is the waiving of clinical efficacy testing due to its lower sensitivity compared to analytical and functional testing and pharmacokinetic profiling. Also questioned is the need to test pharmacodynamic markers that do not correlate with clinical response and find new biomarkers requiring extensive testing to validate their use. Should the FDA accept these scientifically rational suggestions, it will significantly reduce the time and cost of approving biosimilars without safety or efficacy risk, as justified based on acceptable scientific knowledge and rationality.https://www.mdpi.com/1424-8247/16/11/1517biosimilarsFDApharmacodynamic biomarkersclinical efficacy study (CES)BPCIAGASK |
| spellingShingle | Sarfaraz K. Niazi The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of Biosimilars Pharmaceuticals biosimilars FDA pharmacodynamic biomarkers clinical efficacy study (CES) BPCIA GASK |
| title | The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of Biosimilars |
| title_full | The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of Biosimilars |
| title_fullStr | The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of Biosimilars |
| title_full_unstemmed | The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of Biosimilars |
| title_short | The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of Biosimilars |
| title_sort | fda s new guideline generally accepted scientific knowledge gask an opportunity to expedite the approval of biosimilars |
| topic | biosimilars FDA pharmacodynamic biomarkers clinical efficacy study (CES) BPCIA GASK |
| url | https://www.mdpi.com/1424-8247/16/11/1517 |
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