Pharmaceutical Forum 2020. New is the understudied old

“Innovative development faces many barriers, in terms of both regulations and investments, and requires a lot of time: several years, sometimes a decade, may pass from the birth of an idea to the finished product. This encourages us to look for solutions that could potentially lower these risks. One of the most important trends in risk mitigation is working with known molecules to improve their efficacy and safety and to give them additional properties.

This trend is developing and, seeing this, some regulatory systems (for example, the FDA) have adopted regulatory approaches to such innovations, defining them as supergenerics and introducing for this group of products special methods and procedures for research and evaluation, registration and market launch. I would call this category ‘re-innovations’. I want to emphasize that even such a strict regulatory system as the US has created a separate basis for these products and solutions.

By the way, the pandemic, which as a topic runs through all the reports made at our Forum, clearly illustrates the value of this type of innovations, supergenerics. Almost all attempts to tackle the new challenge created by the pandemic involved above all the use of already existing products with antiviral and other properties. It was important that the regulatory system reacted quickly and permitted the use of such medical solutions, having understood and assessed the risks related to potential benefit and harm of such products. This challenge has demonstrated very vividly that supergenerics are a viable idea and can sometimes save many people’s lives.”