Generic drugs account for nearly 90% of prescriptions dispensed in the United States, and their global market is expected to expand, particularly in emerging markets where four of the world’s seven billion people reside. The high usage of generic drugs underscores their critical role in advancing human health globally.
The Potential of Emerging Technologies
Recent years have seen significant advancements in emerging technologies that are transforming the generic drug development landscape. These technologies include:
Sophisticated Quantitative Methods and Computational Modeling: These methods have shown great potential in improving generic drug approval rates by reducing the time and cost of product development. They have informed more efficient study designs for comparative bioequivalence evaluation and have led to the availability of biowaivers for a larger spectrum of products from regulatory agencies such as the European Medicines Agency and the U.S. Food and Drug Administration (FDA).
In-Vitro Biotechnology: Breakthroughs in in-vitro biotechnology, such as the generation and specific differentiation of human induced pluripotent stem cells and organoid technologies, provide new insights into drug responses. These technologies are particularly important in projecting drug effects in limited and middle-income countries where they could have a significant impact.
Computational Models and Data Science: Computational models, such as physiologically-based pharmacokinetic (PBPK) models, can identify potential safety risks. For example, a PBPK model of isoniazid that incorporated genetic variants in NAT2 was able to predict safety and deposition in NAT2-specific patient populations, demonstrating the ability to computationally predict how patients will respond to treatment.
Gene Editing and Gene Writing: Gene editing and gene writing technologies, such as those developed by Tessera Therapeutics and Integra Therapeutics, have the potential to revolutionize healthcare by making genetic medicines widely available for many diseases in diverse geographies.
Challenges and Opportunities
Despite the significant potential of these emerging technologies, there are challenges to their widespread adoption. For instance, the implementation of these technologies may require significant investments in infrastructure and training, which can be a barrier for many generic drug manufacturers, particularly those in resource-limited countries. Additionally, the regulatory framework for these technologies is still evolving, and there may be concerns about the reliability and consistency of these methods.
However, the benefits of these technologies far outweigh the challenges. They offer the potential to significantly reduce the time and cost of generic drug development, improve the quality and safety of generic drugs, and increase access to these drugs in diverse regions. As the FDA continues to support the adoption of innovative approaches to product design and pharmaceutical manufacturing, the generics industry is poised to break the downward spiral of profitability and growth.
Conclusion
The impact of technological advances on generic drug development cannot be overstated. Emerging technologies such as sophisticated quantitative methods, in-vitro biotechnology, computational models, and gene editing and gene writing have the potential to transform the generic drug industry. While there are challenges to their adoption, the benefits of these technologies in improving the efficiency, quality, and safety of generic drugs make them an essential part of the future of generic drug development.
