Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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26 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m is published can be highly variable, which increases the likelihood that such failure modes will remain un- accounted for, despite the multiple review cycle process. As a result, the efficiency of the nation's generic-drug system re- mains suboptimal and prone to frequent negative media cover- age in the form of warning letters and import alerts. The result is to erode the trust and assurance that patients need in order to experi- ence equivalent therapeutic out- comes in the real world. 'New Prior Knowledge' (NPK) would fill this gap by having NIPTE universities conduct research to make available critical information and knowl- edge needed for quality by design of generic-drug products so that multiple generic companies would be able to use the information and compete with high-quality ANDA submissions. NPK would provide a mecha- nism for defining important ge- neric products and identify what are the technical challenges that have to be addressed, design re- search programs around those challenges, and then fund it so that information and knowledge can be curated and published so that it eventually becomes available to all generics companies to in- form their own development pro- grams, and to FDA to improve its own programs. PharmTech: What led to the idea? Hussain: The notion of NPK is based on my experience at Sandoz and collaboration with Momenta; particularly lessons that were learned in the development of generic enoxaparin, generic glat- iramer acetate injection, and bio- similars. Sandoz identified sources of variability and reference prod- ucts and studied reference product so exquisitely in order to know the lot-to-lot variability and failure mode of every component. It took a lot of effort, and we were analyzing and understanding failure modes and sources of variability with the most modern set of orthogo- nal analytical tools. We wanted a deep understanding of the sources of variation and the failure modes so that we could design equivalent products with more confidence, and without failure rates in man- ufacturing. Only a few companies have the resources to do that. Where this information was private at Sandoz, NIPTE would create a public program to gen- erate NPK by characterizing multiple lots of reference prod- ucts via a set of advanced or- thogonal analy tical methods (going well beyond the basic United States Pharmacopeia [USP] testing requirements). PharmTech: Could branded drug companies be expected to share any of this information? Hussain: I do not believe that they would. NIPTE and its 18 member schools seeks to organize a disciplined mechanism to select drugs and drug products that are difficult to develop and that pose a risk of therapeutic inequivalence in the real world. NPK research would be multidisciplinary and among other things, identify fail- ure modes and methodology for analytical characterization. This NPK would be peer-re- viewed, curated, and dissemi- nated publicly, in time for gener- ics companies to inform their development programs and im- prove the quality of their ANDA submissions. FDA would also be able to utilize NPK for their guidance development and to organize their review process. References 1. U S G o v e r n m e n t A c c o u n t a b i l - i t y O f f i c e ( G A O ) , R e p o r t t o Congressiona l Commit tees, Generic Drug Applications, August 2019. 2. A Hussain, V. Gurvich, and R. Morris, AAPS PharmSciTech 20 (3), 140 (2019). PT Generic Pharmaceuticals

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