Advancing Generic Drug Development to Approval

The FDA continuously works to change and improve their work, including the work done with generic drugs. Last month, September 21-22, 2021, the Food and Drug Administration (FDA) hosted a workshop focused on common issues with generic drug applications, research, and more. It was offered to the public as part of the Drug Competition Action Plan as a part of the FDA CDER’s Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI) series. The general goal of these programs is to provide assistance in understanding the regulatory aspects of human drug products & clinical research and make it easier for drug developers to bring generics into the marketplace without losing quality or lowering the standards for approval. The workshop was meant to consider various topics related to generic drugs. (1)

The workshop took place over two days and focused on specific areas related. Some topics of interest included how COVID-19 impacted drug regulation, evaluation, and market release, the use of generic products that are administered orally, nasally, or topically, complex generics, and cutting edge science, Artificial intelligence (AI)  and Nanotechnology in medicine as connected to complex generics. (1)

I hereby would like to share some key features of the workshop with pharmaceutical colleagues.

Generics are very important. 9 out of 10 prescriptions in the U.S. are filled by generics, and during the pandemic, the issue of access to medicines has become especially heightened. The FDA has worked to ensure that people continue to have options for accessible and safe medication during the pandemic and beyond. However, it has led to significant issues with studies, as COVID-19 has imposed various limitations on research, for example, due to travel bans, study site, and laboratory closures as well as product availability. Despite the limitations, the FDA supports the creation of effective research studies that use valid alternatives and maintain a high standard for each procedure despite the circumstances. (2)

Studies have required changes due to the bans, limitations, and concerns with the health and safety of the participants and the researchers, but it is possible to make adjustments with the right justification. The commitment from drug makers should always be to provide safe medication, as this is what the patient expects and relies on. (2)

In regards to these changes, one emerging topic is the use of advanced technologies in the field of generics, which is the use of Artificial Intelligence (AI). AI is revolutionizing a variety of fields, and pharmaceutics is not the exception. Generally speaking, AI technologies offer  opportunities to advance the development and regulatory assessment of generic drugs, which can allow users to enhance efficiency, for instance, by saving time, improving consistency, reducing human error, improving quality, using advanced data analytics, and achieving other results that are likely to make it an asset in the field. AI will play more important role in providing high-quality generic drugs for the U.S. public as more challenges get addressed. (3)

Furthermore, one of the biggest uses of AI to generics will be to support the prediction of Abbreviated New Drug Applications (ANDAs) submission thanks to advanced data analytics. AI models can be combined with existing tools, be employed to integrate domain knowledge and increase the availability of reliable data. AI can work with complex datasets (3). Generics need to have an approved ANDA before being released, and AI can make this process faster and more efficient. In general, ANDA requires a complex bureaucratic process, and AI can reduce the times and resources needed to get a generic on the market without compromising safety. (3)

So far, AI has been used to improve development and regulatory assessment of generic drugs, such as Bioequivalence (BE) assessment, Product-Specific Guidances (PSG) development, business intelligence, and more. Currently, there are challenges that are being addressed little by little. These include access to reliable data, ensuring transparency and interpretability, considering extrapolation, and not enough guidelines to understand how AI should be applied and should not be applied. (3)

In addition, this conference underlines the importance of generics and the continued need to do effective and ethical research to put more generics in the market. Complex generics in particular might require a more involved process and face increased scrutiny. It is especially important to find ways to carry complex generics into the general market. (4)

At present, the FDA recognizes the great value of generics for the market, as their lower prices make them more accessible. However, despite this, the organization needs to take into account the high standards that ensure that the generics, which are used for filling a wide selection of prescriptions, are safe and do what they are supposed to do. A generics approval relies on proving that the drug is the correct pharmaceutical equivalent, that the drug can be made correctly by the manufacturer, that the medical supplies manufacturers can make the drug consistently, that they use the same active ingredient, and with the correct dosage, that the inactive ingredients are safe, that the label and the container are appropriate, that the drug does not break over time, and that the relevant patents and exclusivities are expired. (5) The process can be challenging and is not always understood clearly, so understanding the ins and outs of the technological, biological, pharmaceutical, and legal  processes is essential, as is building networks that connect professionals to the regulatory bodies.

The workshop serves as an officially recognized path towards education, helping industry professionals understand the processes and the particularities involved in generics from different perspectives and approach the process of development, approval, and commercialization with some background knowledge. It also serves as an event to bring closer different stages of the translational science process from basic research to public health, (6) which is especially important with products like generics that have a high usefulness and importance for public health specifically.

What does this event mean for the pharmaceutical industry? The workshop, available for no fee and as a part of a larger program can help medical professionals better understand how to create and launch new generics on a market that desperately needs them. It is a win-win approach for the industry. Materials for the conference can be found on the FDA website and more events in a similar vein are sure to come to improve the generic drug market and the possibility of releasing new generics and other drugs faster and more efficiently. The event updates industry professionals on new developments in regards to generics in relation to various aspects of the topic to support development and approvals.

It is worth mentioning that for translating research and science into impact on health, the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) provides grant opportunities for small businesses in any biomedical or behavioral research area to improve human health. (7) This government funding is designed specifically to transform the translational science process so that new treatments and cures for disease can be delivered to patients more efficiently. The Center also supports the development of new drugs, clinical technology, instruments, medical devices, and related methodologies that may have broad application to clinical research and better patient care. 

References

1. FDA. (2021). Advancing Generic Drug Development: Translating Science to Approval.  https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-translating-science-approval-09212021-09222021#event-information

2. FDA. (2021). Research and Assessment Perspectives. Workshop conference. https://www.youtube.com/watch?v=76oK9kOp3lY

3. FDA. (2021). Use of Artificial Intelligence to Facilitate the Development and Regulatory Assessment of Complex Generic Drugs. Workshop conference. https://www.youtube.com/watch?v=A8IwfrHH5wI

4. Quintiles IMS. (2016). Complex Generics: Charting a new path. https://www.iqvia.com/-/media/library/white-papers/complex-generics-charting-a-new-path.pdf

5. FDA. (2017). What Is the Approval Process for Generic Drugs? https://www.fda.gov/drugs/generic-drugs/what-approval-process-generic-drugs

6. NIH. (2021). Translational Science Spectrum. https://ncats.nih.gov/translation/spectrum

7.   NIH. (2021). https://ncats.nih.gov/smallbusiness/priorities

About the Author

Lin Zhang, M.D., senior director of a health care industry company in the United States. With the experience in clinical medicine, biotechnology, health industry and other fields, he is responsible for the research and development of plant medicine, functional food and health products. He was a clinician and worked for the National Cancer Institute, FDA and the National Cancer Center of Japan for many years.