Helping biosimilars avoid litigation
In a significant move, the US Food and Drug Administration (FDA) is asking for public comments on bioequivalence testing of generic drugs, specifically novel dissolution methods, to allow biowaivers for all types of drugs. The call comes in response to a Citizens Petition filed by Dr. Sarfaraz K. Niazi, Executive Chairman, Pharmaceutical Scientist, Inc., and Adjunct Professor of Biopharmaceutical Sciences at the University of Illinois at Chicago College of Pharmacy and author of dozens of books and research papers on the subject (www.niazi.com).
Dr. Niazi would like to speed the approval process for generic drugs to get medicine to patients as quickly and cost-effectively as possible by using a faster process called thermodynamic equivalence. The FDA has agreed to the validity of Niazi’s argument, in theory at least. In a response letter to Dr. Niazi’s petition, Dr. Janet Woodcock, Director of the Center for Drug Evaluation Research at the FDA, wrote that her department “is largely responsive to your request that we "open comment" on novel dissolution tests that can be used to establish bioequivalence…Therefore, your Petition is granted….” “It has taken years of communication with FDA to reach this stage,” said Niazi.
The focus of expanding biowaivers in the petition calls for establishing a new parameter—thermodynamic equivalence, to obviate the need for blood level studies that significant biologic variability that confounds true differences between products. The suggested change fits well within the purview of the Fair Access for Safe and Timely Generics Act of 2017 or the FAST Generics Act of 2017 and other measures taken by the FDA to allow faster approval of generic chemical and biosimilar drugs. Thermodynamic equivalence demonstration requires identifying dissolution conditions that can discriminate differences in chemical potential, a process created by Dr. Niazi. Thermodynamic equivalence can be used to assure life-cycle clinical equivalence of a generic product and provide a critical measure of GMP compliance.
Now Dr. Niazi is calling on the scientific community to send their feedback to the FDA. “I am encouraging scientists to respond to this challenge and help reduce the cost and time to approval for both chemical and biologic drugs,” said Dr. Niazi. To participate in the public comments, go to https://www.regulations.gov/comment?D=FDA-2007-P-0055-0004 and the correspondence between FDA and Pharmaceutical Scientist, Inc., a global science-driven idea company (www.pharmsci.com).