New Jersey-based Certara has announced that it has received a grant from the U.S. Food and Drug Administration (FDA) to verify and expand biosimulation models for assessing virtual bioequivalence (VBE) in order to enable safer, faster, and cost-effective generic drug production, according to Globe News Wire.
Bioequivalence studies are conducted to ensure the rate and extent of absorption of the experimental product are not significantly different from the brand-name products.
It is important to conduct bioequivalence studies for generic drug approvals. Demonstrating bioequivalence is one of the key regulatory hurdles for generic drug approvals because of the high cost of clinical trials.
However, such hurdles can be tackled using modeling and simulation techniques, such as physiologically-based pharmacokinetic (PBPK) modeling, enabling companies to demonstrate VBE. This eventually helps reduce or eliminate the need for high-cost clinical trials.
Dr. Rob Aspbury, President of Certara’s Simcyp division, said, “We are elated to receive this grant and proud to collaborate with the FDA to help accelerate the drug development process of affordable generic medications. This project is aimed at further demonstrating the predictive performance, reliability, and flexibility of Certara’s biosimulation models, which ultimately benefit patients.”
Dr. Sebastian Polak, Senior Principal Scientist at Certara UK, will serve as principal investigator on the project.
This is Certara’s fourth grant awarded by the FDA for the development of Certara’s Simcyp MechDermA model.
The model was also used to demonstrate bioequivalence for the FDA approval of diclofenac sodium topical gel in 2019 using the agency’s Abbreviated New Drug Application (ANDA) pathway.
Dr. Polak said, “Demonstrating bioequivalence is especially complex for topical, dermatological generic treatments.”
“I am excited to oversee this project, which will further optimize our biosimulation of topical drugs based on skin permeability,” he added. “With this support, we can expand the applicability of our MechDermA model to demonstrate VBE and help to streamline or waive more clinical trials.”
Since 2014, Certara’s customers have received more than 90% of new drug and biologic approvals by the FDA. It is a global leader in accelerating generic medicines using biosimulation software and technology.