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 Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials”.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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Conference to Discuss Scientific and Regulatory Challenges of Complex Drug Development
NEW YORK, October 25, 2016 – On Wednesday, November 9, 2016, a range of experts, industry executives, and government officials will gather at the New York Academy of Sciences for an all-day conference on the topic, "Equivalence of Complex Drug Products: Scientific and Regulatory Challenges." The program is presented by the Academy, the Non-Biological Complex Drugs Working Group and the Nanotechnology Characterization Laboratory (NCL) of the National Cancer Institute's Frederick National Lab for Cancer Research.
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Complex drug products: join the discussion this fall
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. To this end, the group is co-hosting several conferences this fall, on the scientific and regulatory challenges associated with complex drug products.
The 2nd International Symposium on Scientific and Regulatory Advances in Complex Drugs (SRACD 2016) is organized in Budapest, Hungary, October 10-11, as a follow-up of very successful series of Bioequivalence Workshops (BEW series) and the 1st SRACD in 2014, which was the first Symposium in Europe in the field of Biologicals and Complex Drugs. As the science and technologies are advancing, the pharmaceutical world is entering into more complex drug systems and dosage forms. The aim of this symposium is to discuss the scientific advances and regulatory challenges for generic equivalence of these complex drugs. Interested? Visit the conference website.
Together with the Nanotechnology Characterization Laboratory (NCL) and the New York Academy of Sciences, the NBCD working Group organizes the Equivalence of Complex Drug Products: Scientific and Regulatory Challenges conference in New York, USA, November 9. This meeting will bring in experts from around the world to discuss approaches for complex drug development and regulation, challenges in the assessment of complex drug equivalence, and differences and commonalities in the behavior of biological and non-biological complex drug families. Speakers include representatives from academia, industry, and regulatory agencies. Abstracts are being accepted for posters, and two abstracts will be selected for inclusion in the oral presentation program. Click here for more information.
Lastly, the Annual Meeting of the American Association of Pharmaceutical Scientists hosts a symposium on this topic in Denver, USA, November 13-17. The symposium addresses a series of recent progress in analytical techniques to characterize these nanomedicines/NBCD products in detail and to understand what characteristics are crucial to their performance as a formulated product and/or in clinical testing. This will stimulate science-based discussion between scientists, drug developers (of novel nanomedicines and follow-on versions), regulators, and other stakeholders to further our thinking on these challenging issues. Find out more about the AAPS conference here.
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NBCD Working Group participates in FDA Public Hearing
On 20 May 2016, the FDA organized a Public Hearing on the current status of the regulatory science initiatives for generic drugs. The hearing provided an opportunity for public input on research priorities in these topic areas. The NBCD Working Group highly values the opportunity to provide input to the FDA to solve the challenges in the field of complex drugs, and participated in the hearing. Following earlier presentations of the working group at previous Public Hearings, this time the challenges in establishing similarity for ophthalmic emulsions were addressed.
The FDA has indicated to take the information it obtains from the public meeting into account in developing the fiscal year (FY) 2017 Regulatory Science Plan.