Cancer lab to evaluate bioequivalence of nanosimilars

Non‐Biological Complex Drugs/News | Posted 23/09/2016 post-comment0 Post your comment

The Frederick National Laboratory for Cancer Research (Frederick National Lab) announced on 10 June 2016 that it was collaborating with the US Food and Drug Administration (FDA) on the characterization of nanosimilars.

Nanoparticle V13J18

The Frederick National Lab is a federal national laboratory sponsored by the National Cancer Institute, which is part of the US National Institutes of Health.

The lab’s Nanotechnology Characterization Laboratory (NCL) has entered into an interagency agreement with FDA for evaluating the bioequivalence of generic nanomedicines (or follow-on nanomedicines or nanosimilars) compared with their brand-name counterparts.

FDA does not formerly recognize non-biological complex drugs (NBCDs), of which many are nanomedicines. Originators are required to follow the new drug application (NDA) route and follow-on NBCDs using the generics – abbreviated new drug application (ANDA) – route [1].

However, like biologicals, NBCDs consist of different (closely related) structures that cannot be fully characterized or described by (physico)chemical analytical tools. The composition and quality of NBCDs are dependent on the manufacturing process and controls – just as is the case with biologicals. Therefore, approval of follow-on NBCDs via generics pathways may not be appropriate and use of biosimilars pathways for non-biologicals is also not appropriate.

According to NCL scientist Jennifer Grossman, ‘FDA is looking to us to develop novel methods that will potentially help the regulatory process for approval of generic nanomedicines’.

Under the agreement, NCL will apply a method for measuring the active ingredients from several drug products, whether the drug is still bound with the nanoparticle or free in the bloodstream. It will also conduct in vitro and in vivo drug release studies relevant to establishing bioequivalence. NCL will coordinate with the FDA to select the most appropriate drug products for evaluation, as well as criteria for evaluating performance of the method.

The NCL–FDA agreement stems from a Government Accountability Office study assessing FDA’s regulatory pathway for reviewing follow-on NBCDs.

The issue of whether FDA’s pathway is appropriate or not has also been raised in a Congress bill, which was introduced by Michael Burgess, a former physician and member of the House Energy and Commerce Committee, in March 2015. The Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 (HR1576) aims to investigate whether a new pathway – like that for biosimilars – needs to be introduced for complex drugs [2].

Related articles
EU guidelines for follow-on NBCDs

Regulations for follow-on NBCDs

1. GaBI Online - Generics and Biosimilars Initiative. Regulations for follow-on NBCDs []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 23]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Is a new pathway for NBCDs on the way in the US? []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 23]. Available from:

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.

Source: Frederick National Lab

comment icon Comments (0)
Post your comment
Related content
FDA approves 40 mg follow-on version of glatiramer acetate
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