Vinod P. Shah, Ph.d., is a retired senior research scientist from FDA.
Daan J.A. Crommelin, Ph.d., is emeritus professor at Utrecht University.
From a scientific point of view, the development of a generic low molecular weight drug is relatively straightforward. If one demonstrates the pharmaceutical equivalence and bioequivalence of the drug between originator and its generic version, the generic product is labeled as therapeutically equivalent and interchangeable with the originator product. In that case, in many countries products can be used as if they are the same.
The challenge significantly increased with the rise of biotechnology. Complex products were marketed and after several years, the development of “generic versions” of biological medicines (aka biosimilars) started. The development of the biosimilar concept has raised lively discussions, not only in the European Union and in the United States but worldwide. Regulatory agencies everywhere are developing policies on how to deal with these types of new medicines, especially with respect to substitution and interchange.
There is another category of medicines of growing importance but currently not falling into the category of biologicals where ”similar” issues are under discussion. These medicines are the so-called nonbiological complex drugs (NBCDs). NBCDs are medicinal products, not being a biological medicine, where the active substance is not a homomolecular structure but consists of different (closely related and often nanoparticulate) structures that cannot be isolated and fully quantitated, characterized, and/or described by physicochemical analytical means. Examples of NBCDs are the families of the liposomal drugs, glatiramoids, and iron-sugar complexes and can include members of the family of nanomedicines and upcoming associated nanosimilars.
Within the context of the NBCD Working Group, a public-private partnership with worldwide representation, we have been working on the scientific challenges that are related to NBCD and their follow-on versions. During workshops in different countries and with input from industry, academia, and regulatory bodies we try to find common ground regarding the question: How to deal with NBCD and associated challenges in the regulatory environment?
These discussions are almost as complex as the products themselves. Over the years, we realized that all stakeholders developed their own terminology. A common, globally used terminology is lacking and would significantly help an efficient discussion. Our attempt to define the terminology in this field and to review the current state of affairs with respect to NBCDs is now published in The AAPS Journal.
We invite you to actively participate in our discussions on the current state of affairs of NBCDs and regulatory paradigms of follow-on versions. Join us at the symposium Are Generic Non-biological Complex Drugs (NBCDs) Therapeutically Equivalent? at the 2013 AAPS Annual Meeting and Exposition in San Antonio.
More About the Authors
Jon S. B. de Vlieger, Ph.D., obtained his doctoral degree in bioanalytical chemistry from the VU University in Amsterdam. He is involved in the strategy department of the Dutch Top Institute Pharma, a not-for-profit organization catalyzing the development of medicines by establishing partnerships and actively managing research programs.
Vinod P. Shah, Ph.D., is a pharmaceutical consultant. He retired as a senior research scientist from FDA after 30 years of service in 2005. He was the scientific secretary for FIP from 2003 to 2011 and is a steering committee member of NBCD.
Daan J. A. Crommelin, Ph.D., is emeritus professor at the department of pharmaceutics at Utrecht University and publishes extensively in the field of advanced drug delivery and pharmaceutical biotechnology. He was the scientific director of the Dutch Top Institute Pharma, a public private partnership.