Regulatory Focus™ > News Articles > FDA to Spend $1 Million to Develop Mathematic Model of Drug Sameness and Similarity

FDA to Spend $1 Million to Develop Mathematic Model of Drug Sameness and Similarity

Posted 20 May 2014 | By Alexander Gaffney, RAC 

FDA to Spend $1 Million to Develop Mathematic Model of Drug Sameness and Similarity

Drug regulators with the US Food and Drug Administration (FDA) are pursuing the development of new technologies to better understand generic—and perhaps even biosimilar—drugs.

In a 19 May 2014 funding announcement posted on the National Institute of Health's website, FDA explained that it's seeking help in developing a mathematical algorithm or model it can use to integrate various information to better understand which data can demonstrate "similarity or sameness of the follow-on or generic version of macromolecules or complex drug substances to their reference products."

FDA said the data obtained in the study should help it to provide a "coherent picture" of drug complexity, allowing it to determine which types of studies will be needed to determine sameness or similarity.

"In order to rely on the in vitro approaches to demonstrate similarity (or sameness) for complex molecules, it will be useful to develop a bioinformatic-type approach to determine whether the type and number of in vitro chemical and biological characterization assays employed are sufficient to establish the sameness or similarity between the reference and follow-on (or generic) drug products for the complex molecules," FDA wrote.

The proposed study will involve four phases: the selection of two drug products; the development and utilization of high-resolution chemical and biological assays to characterize multiple batches of the selected drugs; development of a mathematical algorithm model to integrate chemical and biological characterization data to demonstrate similarity or sameness among multiple batches of the same product; and the validation of the model.

FDA said it hoped that the new approach would be feasible based on improvements and advances in analytics, which it said now allows for the characterization of complex molecules at molecular levels.

The three-year project is being run by the Center for Drug Evaluation and Research (CDER) and is expected to cost $1,000,000.

Applications for the project are due by 30 June 2014.

FDA Funding Notice


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