, Dec. 3, 2019
/PRNewswire/ -- In a significant policy shift, the US FDA has released a guidance for insulin biosimilars on 26 November 2019
[see below, FDA Insulin Guidance] waiving clinical immunogenicity and comparative efficacy testing if the biosimilar insulin candidate matches the analytical and pharmacokinetic/pharmacokinetic attributes, as suggested in a Citizen Petition [see below Niazi Petition] filed by Prof. Sarfaraz Niazi
, CEO of Pharmaceutical Scientist, Inc. Niazi had questioned the validity of comparative efficacy testing of biosimilars based on the inevitable arbitrariness of the equivalence interval chosen, the irrationality of relying on only a single study to obtain extrapolation of multiple indications and the impossibility of securing sufficient naďve patients to make the studies reliable. The weaknesses of clinical efficacy testing are now well recognized by the FDA; Dr. Janet Woodcock
, head of CDER at the FDA has stated that the "current system of clinical trials is broken," and the FDA will not approve a biosimilar based on a comparative efficacy testing if other attributes fail to compare. According to Niazi, "a human or animal testing should only be considered if it provides a definitive assessment of the safety and efficacy, otherwise it is tantamount to abuse of humans and animals."
"The new insulin guidance is the first clear statement by the FDA to waive comparative efficacy testing that will extend to other biological drugs saving billions of dollars to the US patients," Niazi predicts. It is now up to the biosimilar developers to create intelligent development plans to convince the FDA to reduce the burden of testing.
Niazi further projects that the insulin prices will soon drop significantly to resolve the cost issues pointed out in Congressional Bills such as the S.2199 - Insulin Price Reduction Act.
The current move by the FDA is the second action based on the recommendations in the Niazi petition; the first action withdrew the guideline "Statistical Approaches to Evaluate Analytical Similarity" on 21 June 2018
and replaced it with a more scientific analytical assessment plan. (See Forbes
FDA Insulin Guidance: https://tinyurl.com/sm4ewe4
Niazi Petition: https://tinyurl.com/y9okcwhy
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SOURCE Pharmaceutical Scientist, Inc.