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

References
1. GaBI Online - Generics and Biosimilars Initiative. Regulations for follow-on NBCDs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 23]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/Reports/Regulations-for-follow-on-NBCDs
2. GaBI Online - Generics and Biosimilars Initiative. Is a new pathway for NBCDs on the way in the US? [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 23]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/Polices-Legislation/Is-a-new-pathway-for-NBCDs-on-the-way-in-the-US

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