Non-Biological Complex Drugs (NBCDs) and their follow-on versions: time for an editorial section

Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Stefan Mühlebach, PhD; Vinod P Shah, PhD; Scott E McNeil, PhD; Professor Gerrit Borchard, PharmD, PhD; Vera Weinstein, PhD; Beat Flühmann, PhD; Sesha Neervannan, PhD; Professor Daan JA Crommelin, PhD Abstract: This paper discusses the group of non-biological complex drug (NBCD) products and presents the reasons why […]


Clinical development, immunogenicity, and interchangeability of follow-on complex drugs

Abstract: Although not derived from living sources, non-biological complex drug (NBCD) products have the immunogenicity and molecular complexity of biological drugs. NBCDs typically contain heterogenous mixtures of closely related nanoparticulate components that cannot be isolated, quantified, or entirely characterized physicochemically. Development of follow-on versions of NBCDs poses many of the same scientific challenges associated with […]