The FDA’s New Guideline “Generally Accepted Scientific Knowledge” (GASK): An Opportunity to Expedite the Approval of Biosimilars

Author:

Niazi Sarfaraz K.1ORCID

Affiliation:

1. College of Pharmacy, University of Illinois, Chicago, IL 60612, USA

Abstract

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.

Publisher

MDPI AG

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Reference118 articles.

1. U.S. Food and Drug Administration (2023). Notice of Availability, Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry; Availability. Fed. Regist., 88, 33887–33888.

2. (2023, September 22). Available online: https://www.govinfo.gov/app/details/BILLS-117s5002cps.

3. (2023, July 15). Available online: https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/role-pharmacodynamic-biomarkers-biosimilar-drug-development.

4. (2023, September 22). Available online: https://www.fda.gov/media/78946/download.

5. (2023, September 22). Available online: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information.

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