Harmonization of requirements for NBCDs across regions Posted 21/04/2017

Efforts are being undertaken to continuously develop and harmonize the regulatory requirements for complex medicinal products across regions. Taking this into account, authors Ehmann and Pita believe the European Union (EU) network is ready for non-biological complex drugs (NBCDs) [1].

Like biologicals, non-biological complex drugs (NBCDs) consist of different (closely related) structures that cannot be fully quantitated, 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. Examples of NBCDs include nanomedicines, such as liposomes, polymeric micelles, glatiramoids, iron-carbohydrate complexes and nanocrystals, as well as dry powder inhalers.

In its revised overarching biosimilars guideline, the European Medicines Agency (EMA) allowed for the use of a non-EEA (European Economic Area) authorized comparator or reference product. This, the agency said, was done ‘with the aim of facilitating the global development of biosimilars and to avoid unnecessary repetition of clinical trials’ [2].

Like biosimilars, follow-on NBCDs may also require extensive in vivo comparability data. Ehmann and Pita therefore believe that ‘the flexibility accorded to biosimilars could be extended for NBCDs allowing for non-EEA reference medicinal products to be used, thus decreasing the need for duplicate studies of applicant wishing to apply for an abridged application in the EU and in another ICH [International Council for Harmonisation] country’.

Ehmann and Pita mention efforts being made to harmonize EU and US regulation by moving forward towards recognizing each other’s reference medicinal products. However, a number of experts from the Steering Committee of the NBCD Working Group of Lygature point out to the case of follow-on versions of low-molecular weight heparins. These are not considered biologicals in the US, but are in Europe, where they are seen as biosimilars [3].

Efforts to facilitate the worldwide harmonization of nanotechnology regulation are being demonstrated by the work of the International Pharmaceutical Regulators Forum (IPRF). The IPRFs purpose is to create an environment for pharmaceutical regulators to exchange information on issues of mutual concern and regulatory cooperation [4]. A special IPRF Working Group on Nanotechnology was created in 2014 and its mandate and 2015/2016 work plan were adopted and published in 2015. The experts from the Steering Committee of the NBCD Working Group of Lygature point out, however, that ‘no concrete results’ have been reported so far. They also add that although the World Health Organization (WHO) has taken the initiative to draft a WHO regulatory protocol for biosimilars, it has not started such an initiative for follow-on NBCDs [3].

Conflict of interest
The authors of the research paper [1] declared that the views expressed are those of the authors and should not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency.

The authors of the research paper [3] declared that the views expressed are those of the authors and should not be understood or quoted as being made on behalf of or reflecting the position of the individual organizations or the NBCD Working Group as a whole. 

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Related articles
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Is the EU ready for non-biological complex drug products?

References
1. Ehmann F, Pita R. The EU is ready for non-biological complex medicinal products. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(1):30-5. doi:10.5639/gabij.2016.0501.008
2. GaBI Online - Generics and Biosimilars Initiative. EMA issues revised version of overarching biosimilars guideline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 21]. Available from: www.gabionline.net/Guidelines/EMA-issues-revised-version-of-overarching-biosimilars-guideline
3. de Vlieger JSB, Borchard G, Shah,VP, Flühmann B, Neervannan S, Mühlebach S. Is the EU ready for non-biological complex drug products? Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(3):101-2. doi:10.5639/gabij.2016.0503.026
4. GaBI Online - Generics and Biosimilars Initiative. The role of the IPRF in transparency for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 21]. Available from: www.gabionline.net/Reports/The-role-of-the-IPRF-in-transparency-for-biosimilars

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