A conference on ‘Equivalence of Complex Drug Products: Scientific and Regulatory Challenges’

Non‐Biological Complex Drugs/News | Posted 09/09/2016 post-comment0 Post your comment

A conference presented by the Non-Biological Complex Drugs Working Group (NBCD WG), the Nanotechnology Characterization Laboratory (NCL) of the Frederick National Lab for Cancer Research, and the New York Academy of Sciences on ‘the Equivalence of Complex Drug Products: Scientific and Regulatory Challenge’, Wednesday, 9 November 2016, from 8:30 am to 5:15 pm in New York, USA.

NBCD 2

The rise of bio- and nano-technologies has accelerated the development of complex drug products, a class of products that include – but are not limited to – Non-Biological Complex Drugs (NBCDs). NBCDs, e.g. glatiramoids, iron-carbohydrate complexes, polymeric micelles, complex ocular emulsions and liposomes, consist of different (closely related and often nanoparticulate) structures that cannot be fully quantitated and characterized by physicochemical analytical means. 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. While guidance for developing generic versions of small molecule drugs is well established, and progress has been made for biological complex drugs, there is very little guidance for follow-on versions of NBCDs. This is further complicated by the difficulty of aligning strategies of international regulatory bodies due to their different legal frameworks. To advance research and build consensus, it is necessary to engage together key stakeholders from academia, regulatory bodies, industry and drug manufacturing.

To stimulate this discussion, the above-mentioned organizations present this one-day conference: Equivalence of Complex Drug Products: Scientific and Regulatory Challenges. This convening aims to identify the best approaches for complex drug development and regulation, to outline outstanding challenges in the assessment of complex drug equivalence and consequences for interchangeability of products, to address whether the regulatory approaches for biosimilars should be used as models for other complex drugs, and to clarify differences and commonalities in the behavior of biological and NBCD families. The end goal is to facilitate the translation of scientific findings into advancements in medicine and to ensure the safety and benefit of patients.

Full details of this conference, including the programme and speaker details, can be found on: www.nyas.org/ComplexDrugs16

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
FDA approves 40 mg follow-on version of glatiramer acetate
NBCD ASEAN V16F09BF S69 V16F20JM
Non‐Biological Complex Drugs/News Posted 09/03/2018
Mylan launches first follow-on glatiramer acetate in the UK
Multiple Sclerosis V14A24
Non‐Biological Complex Drugs/News Posted 15/02/2018
Impax announces FDA approval of follow-on sevelamer carbonate
Nanoparticle V13J18
Non‐Biological Complex Drugs/News Posted 17/11/2017
FDA approves follow-on version of sevelamer
99 AA010633
Non‐Biological Complex Drugs/News Posted 30/06/2017
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010