Projects
Non-Biological Complex Drugs (NBCD) Working Group
Towards aligned, science-based approval and post-approval standards for non-biological complex drugs
The Non-Biological Complex Drugs Working Group was established in 2009, to stimulate discussion of the safety and efficacy of NBCD innovation and follow-on products.
15
papers, 3 blogs and 1 book published
5
partners from industry and academia
About NBCDs
Non-biological complex drugs (NBCDs) consist of different (closely related and often nanoparticulate) structures that cannot be fully quantitated and characterized by physico-chemical analytical means. Examples include glatiramoids, iron-carbohydrate complexes, polymeric micelles, complex ocular emulsions and liposomes. The complex nature of NBCDs means that minute variations in the manufacturing process can substantially change the composition of final products, and this poses a challenge for the development of regulatory guidelines. The working group aims to ensure patient benefit through a science-based approach for the approval of NBCD products and follow-on versions.
For more information visit our website.
Key publications
- 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
- K.Klein, P.Stolk, M.L.De Bruin, H.G.M.Leufkens, D.J.A.Crommelin, J.S.B.De Vlieger. The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations. European Journal of Pharmaceutical Sciences, Volume 133, 15 May 2019, Pages 228-235.
- de Vlieger, J.S.B., Crommelin, D.J.A., Tyner, K. et al. Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials”. AAPS J 21, 56 (2019).
- Hussaarts et al. 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)
- Crommelin and de Vlieger, 2015 (Eds.), Non-Biological Complex Drugs. The Science and the Regulatory Landscape; AAPS/Springer, Advances in the Pharmaceutical Sciences Series, NY.
- Crommelin et al. Different pharmaceutical products need similar terminology; AAPS J. 2014 Jan;16(1):11-14.
- Schellekens et al. How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider; AAPS J. 2014 Jan;16(1):15-21.
A list of NBCD-related publications co-authored by Lygature can be found on this page.
Driving science-based discussions
The NBCD Working Group was established following a scientific workshop organized by TI Pharma – now Lygature. The partnership brings together both industry partners and international experts, who engage in debate with a wide range of relevant stakeholders. Lygature provides the necessary support and scientific expertise, to ensure that discussions are inclusive and productive. Activities include:
- Scientific management. Lygature is responsible for scientific management and organizational aspects of the working group as a whole. Responsibilities include general project management, management of strategic alliances and alignment with relevant stakeholders.
- Provider of neutral ground. As an independent third party with no commercial interest, Lygature has hosted the NBCD Working Group from the beginning, and provides neutral ground to facilitate discussion between stakeholders.
- Communication & dissemination. An important contribution by Lygature is communication and dissemination, with the aims of establishing terminology and creating awareness of the challenges faced. Activities include: presenting at international conferences; (co-)writing of scientific articles, white papers and blogs; organization of conferences; and brand building.
The NBCD Working Group contributes strongly to Lygature’s mission of accelerating the launch of medicines that improve society's wellbeing. Since stakeholders often have different interests, the project has required extensive management capabilities, along with expertise in both science and the regulatory landscape.
Lygature together with
Project updates
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Non-biological complex drugs at CLINAM Annual Summit
The 2018 edition of the European Foundation for Clinical Nanomedicine (CLINAM) Annual Summit will feature a session on Non‐Biological Complex Drugs (NBCDs), on Tuesday 4 September. The impressive program includes speakers from FDA, EMA, Health Canada, knowledge institutions and more.
The speakers will focus on global clinical experience with NBCDs and their follow-ons, as well as recent steps that are being taken to globally align the regulatory processes. Prof. Daan Crommelin and Prof. Stefan Mühlebach from the NBCD Working Group will chair the session.
The 11th edition of the CLINAM summit will take place in Basel, covering the interdisciplinary fields of clinical and targeted nanomedicines in major and neglected diseases. For more information, visit https://www.clinam.org/.
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Non-biological complex drugs: join the discussion this spring
The Non-Biological Complex Drugs (NBCD) Working Group has the mission to ensure patient safety and benefit by driving discussions on science-based approval and post-approval guidelines for NBCDs. This spring, members of the working group will be presenting at the EUFEPS Annual Meeting and the 3rd Global Bioequivalence Harmonization Initiative (GBHI) conference.
The EUFEPS Annual Meeting brings together scientists from academia, industry and regulatory authorities and will be focused on the theme “Crossing Barriers for Future Medicines”. Nanomedicines and regulatory science are main tracks of the meeting held in Athens, Greece between May 24-26. Gerrit Borchard will be presenting on 24 May, discussing identification of critical quality attributes for nanomedicines.
The 3rd GBHI conference will feature regulatory, academic, and industry speakers from North America and Europe as well as speakers from regulatory agencies from Asia and South America in Amsterdam, The Netherlands from April 11-13, 2018. Daan Crommelin will give a presentation on 13 April, entitled: “Generic liposome products: adequate bioequivalence criteria and therapeutic implications.”
Are you interested in meeting members of the NBCD Working Group? Please contact Jon de Vlieger, NBCD Working Group Coordinator.
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US GAO Report Identifies Challenges for Generic Versions of Nonbiological Complex Drugs
On January 16, 2018, the U.S. Government Accountability Office (GAO) released a report that examines the challenges of reviewing generic versions of nonbiological complex drugs (NBCDs). The report underlines the scientific challenges involved when demonstrating equivalence between brand and generic NBCDs. GAO recommends that FDA increases transparency, and publicly announces its plans to issue and revise guidance for complex drugs.