Publications
Publications on Non-Biological Complex Drugs
The first publications addressing the regulatory challenges associated with non-biological complex drugs (NBCDs) appeared in 2011, and TI Pharma - now Lygature - contributed knowledge from the start. A list of NBCD-related publications co-authored by our team can be found on this page.
Papers
- Klein, K., Borchard, G., Shah, V.P., Flühmann, B., McNeil, S.E. and de Vlieger, J.S.B. (2021), A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways. Ann. N.Y. Acad. Sci.. https://doi.org/10.1111/nyas.14662
- Jon SB de Vlieger; Daan JA Crommelin; Beat Flühmann; Imre Klebovich; Stefan Mühlebach; Vinod P Shah. A progress report on the 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs: A to Z in Bioequivalence. Generics and Biosimilars Initiative Journal (GaBI Journal) Volume 8, Issue 3 (2019).
- Klein K, Stolk P, De Bruin ML, Leufkens HGM, Crommelin DJA, De Vlieger JSB. The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations. Eur J Pharm Sci. 2019 May 15;133:228-235. doi: 10.1016/j.ejps.2019.03.029. Epub 2019 Apr 3. Review.
- De Vlieger JSB, Crommelin DJA, Tyner K, Drummond DC, Jiang W, McNeil SE, Neervannan S, Crist RM, Shah VP. Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: "Drug Products, Including Biological Products, that Contain Nanomaterials". AAPS J. 2019 Apr 17;21(4):56.
- Hussaarts L., Mühlebach S., Shah VP., McNeil S., Borchard G., Flühmann B., Weinstein V., Neervannan S., Griffiths E., Jiang W., Wolff-Holz E., Crommelin DJA., de Vlieger JSB. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks. Ann N Y Acad Sci Apr 26. [Epub ahead of print] (2017)
- Flühmann, B., de Vlieger, J. S., & Borchard, G. Is the EU ready for non-biological complex drug products? Generics and Biosimilars Initiative Journal (GaBI Journal) 5, 101-2. (2016)
- de Vlieger, J. S., Mühlebach, S., Shah, V. P., Flühmann, B., Neervannan, S., & Crommelin, D. J. Non-Biological Complex Drugs (NBCDs) and their follow-on versions: time for an editorial section. Generics and Biosimilars Initiative Journal (GaBI Journal) 4, 167-170. (2015)
- Crommelin, D. J., Shah, V. P., Klebovich, I., McNeil, S. E., Weinstein, V., Flühmann, B., & De Vlieger, J. S. The similarity question for biologicals and non-biological complex drugs. European Journal of Pharmaceutical Sciences 76, 10-17 (2015)
- Crommelin, D. J., de Vlieger, J. S., Weinstein, V., Mühlebach, S., Shah, V. P., & Schellekens, H. Different pharmaceutical products need similar terminology. The AAPS journal 16, 11-14. (2014)
- Schellekens, H., Stegemann, S., Weinstein, V., de Vlieger, J. S., Flühmann, B., Mühlebach, S., & Crommelin, D. J. How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider. The AAPS journal 16, 15-21. (2014)
- Mühlebach, S., Vulto, A., de Vlieger, J., Weinstein, V., Flühmann, B., & Shah, V. P. The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead. Generics and Biosimilars Initiative Journal (GaBI Journal) 2, 204-207. (2013)
- Holloway C., Mueller-Berghaus J., Lima B.S., Lee S.L., Wyatt J.S., Nicholas J.M., Crommelin D.J. Scientific considerations for complex drugs in light of established and emerging regulatory guidance. Ann N Y Acad Sci. 1276, 26-36. (2012)
- Schellekens, H., Klinger, E., Mühlebach, S., Brin, J. F., Storm, G., & Crommelin, D. J. The therapeutic equivalence of complex drugs. Regulatory toxicology and pharmacology 59, 176-183. (2011)
Books
- Crommelin, D. J., & de Vlieger, J. S. (Eds.). Non-biological complex drugs: the science and the regulatory landscape 20. Springer. (2015).