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Biowaivers to eliminate be testing
After working with FDA guidance for over 30 years, we have now introduced a concept of thermodynamic equivalence that stands to make human testing for bioequivalence obsolete for all dosage forms. FDA has opened up a portal for comments and we have designed protocols that can help you take your generic product to market faster.
Bioequivalence Waivers Using Thermodynamic Equivalence Testing
A Citizens Petition filed by Dr. Sarfaraz K. Niazi, Adjunct Professor of Biopharmaceutical Sciences at the College of Pharmacy, University of Illinois, Chicago, a well-recognized authority on bioequivalence testing, having written dozens of books on the subject, and having hands on experience in conductive bioequivalence and biosimilarity testing, was granted by FDA. In a response letter to Dr. Niazi, Dr. Janet Woodcock, Director, CDER, wrote: “We believe that the current system of publishing product-specific recommendations for generic drug development, in conjunction with our other efforts to obtain public input on and disseminate our current thinking on bioequivalence testing methodologies, is largely responsive to your request that we "open comment" on novel dissolution tests that can be used to establish bioequivalence. These initiatives and efforts inform how we exercise our discretion to recommend a particular method for demonstration of bioequivalence or specific study design fora proposed generic product, and enable us to advance our regulatory science more generally with regard to bioequivalence testing. Therefore, your Petition is granted in part to the extent that it asks us to open comment on novel dissolution tests that can be used to establish bioequivalence”. The focus of expanding biowaivers in the petition is based on establishing a new parameter—thermodynamic equivalence, to obviate the need to examine differences in products by adding large biologic variability, an approach that 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 and biosimilar drugs.
Blood level testing (PK studies) are not required by statute that defines bioequivalence as a measure of concentration at the "site of action." that is in most cases not known, and rarely accessible; as a result, the FDA suggested blood level studies as a "surrogate test." This assertion followed the system of biowaivers where the risk of equivalence is minimal, such as highly soluble and easily penetrable drugs. While biowaivers have reduced some burden, a scientific basis of measuring the chemical potential of a dosage form remains the best surrogate test for therapeutic equivalent, as proposed by Dr. Niazi. The variability of biological factors confounds the difference between products and inevitably requires expensive large studies to establish equivalence if thermodynamic equivalence is demonstrated--from this point forward, the interaction of drug molecules will be similar. Dissolution rate is one measure of thermodynamic potential of a dosage form but creating a model, such as through novel dissolution conditions, not necessarily emulating any physiologic process, allows a side-by-side demonstration of equivalence.
The FDA is always responsive to scientific arguments and now we have an opportunity to change the course of development of chemical generic and biosimilar drugs by responding to there challenge given by the FDA.
Click here to download an introductory document on thermodynamic testing.
Please write to Dr. Niazi, if you wish to receive details on how to design thermodynamic equivalence studies that will be acceptable to the FDA for awarding biowaivers.
fast to market biosimilars
We wrote the book on biosimilars, even before the term was coined and the followed up with many more. For over 22 years, we have developed and taken to market biosimilars across the globe and more particularly in the US. There is a critical science needed to avoid the pitfalls that delay filing of biosimilars, we have understood and ready to share with you. This involves adding our proprietary technology and patents to reduce the need for phase 3 studies, provide a more convincing analytical similarity and prepare you for interchangeable biosimilar filing. More details.
smart technology to control cogs
From single-use fermentors now in use for GMP manufacturing to the design of the lowest cost manufacturing facility to novel analytical testing to eliminate phase 3 studies, we have revolutionized the development and manufacturing of pharmaceuticals and biopharmaceuticals. No longer do we have to spend billions to create new products. Proven and in practice, and now available to the world. More details.