The NBCD working group has been set up to discuss appropriate and harmonized science-based approval and post-approval standards to ensure patient safety and benefit with Non Biological Complex Drugs (NBCD). The working group engages in activities to disseminate the corresponding scientific evidence to authorities, experts, health care providers and other relevant bodies with responsibility for treatment with NBCD. Moreover the group is involved in scientific education and training on the above mentioned topics to relevant stakeholders.

A Non Biological Complex Drug is defined as a medicinal product, not being a biological medicine, where the active substance is not a homo-molecular structure, but consists of different (closely related) structures that can't be fully quantitated, characterized and/or described by (physico-) chemical analytical tools. The composition and quality of NBCD are dependent on the manufacturing process and controls.

In contrast to small molecule drug products, full pharmaceutical characterization of the API and established therapeutic equivalence standards are lacking for NBCD. Therefore, the process for the approval of generic small molecules drugs may not always be adequate for NBCD. While for biosimilars new registration pathways have been introduced in many countries that are different from those for small molecules, for NBCD no comprehensive regulatory guidance does exist.

In order to guarantee patient's safety and benefit, regulatory guidance addressing the specificities of NBCD is therefore needed.

Hosted at TI Pharma, the NBCD working group consists of international experts from industry, academia and knowledge institutes. Currently, the NBCD working group is supported by Vifor Pharma International Inc., Teva Pharmaceutical Industries Ltd. and Sanofi-Aventis Groupe.


Recent publications on NBCD and related topics:

  • Schellekens, H. et al. The therapeutic Equivalence of Complex Drugs 'the Leiden Paper'; Regul Toxicol Pharmacol 2011 Feb;59(1):176-83.
  • Holloway, C. et al. Scientific considerations for complex drugs in light of established and emerging regulatory guidance; Ann N Y Acad Sci. 2012 Nov 29. doi: 10.1111/j.1749-6632.2012.06811.x
  • Schneider, C. et al. In support of the European Union Biosimilar Framework ; Nat. Biotechnol. 30, 745-747 (2012).
  • Borchard, G. et al. Nanoparticle iron medicinal products - Requirements for approval of intended copies of non-biological complex drugs (NBCD) and the importance of clinical comparative studies; Regul Toxicol Pharmacol 2012;64: 324-328
  • How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider.
    Schellekens H, Stegemann S, Weinstein V, de Vlieger JS, Flühmann B, Mühlebach S, Gaspar R, Shah VP, Crommelin DJ. AAPS J. 2013 Sep 25.
  • Different Pharmaceutical Products Need Similar Terminology. Crommelin DJ, de Vlieger JS, Weinstein V, Mühlebach S, Shah VP, Schellekens H. AAPS J. 2013 Sep 25.

“The experience that TI Pharma has from putting together partnerships to research neglected diseases is really valuable, because it applies across other therapeutic diseases.”

Tim Wells
Chief Scientific Officer
Medicines for Malaria Venture

Share this page: