Transparency and quality characteristics for biosimilars

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Under the auspices of increased transparency for biosimilars the European Medicines Agency (EMA) has outlined the different means available for publishing quality information on biosimilars.

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In his presentation [1], at the 14th Annual European Biosimilars Group Conference, Dr Peter Richardson, Head of the Quality Office at the European Medicines Agency (EMA), discussed quality characteristics published for biosimilars approved in the European Union (EU).

Information on the quality aspects of biosimilars is available via the Public Assessment Summary Information for Biosimilars (PASIB), European Public Assessment Reports (EPARs), US Food and Drug Administration (FDA) Advisory Committee Meeting reports and EU examples.

For example, the PASIB for the biosimilar Herzuma (trastuzumab) includes, in a tabular form, information on the physicochemical testing methods used and the assays used to compare biological activity with the reference product. It also includes the outcomes of the quality data assessment, i.e. whether comparable or not, as well as any remarks concerning this comparability (or lack of).

In contrast, the EPAR for the etanercept biosimilar Benepali (SB4) includes a description of how the characterization of the biosimilar was carried out using appropriate techniques as described in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q6B.

A further example, taken from a FDA arthritis advisory committee meeting for the infliximab biosimilar (Inflectra/Remsima; CT-P13), also summarizes quality information on the comparison of the biosimilar in a tabular form. Again giving details of the different tests used to determine similar efficacy, safety and immunogenicity, as well as giving an estimation of the potential impact of any differences.

No matter in what form they are presented the information provided by the various sources represents a substantial increase in transparency with respect to the quality aspects of biosimilars.

Editor’s comment
Readers interested to learn more about transparency for biosimilars are invited to visit to view the following manuscript published in GaBI Journal:

Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016

GaBI Journal is indexed in Embase, Scopus, Thomson Reuters’ ESCI, and more.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal, please send us your submission here.

If you would like to receive a PDF copy* of the Richardson presentation [1], please send us an email.

*For profit organizations subjected to a fee

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Achieving international regulatory convergence for biosimilars

1. Richardson P. EMA Biosimilar update: International Regulatory Convergence. 14th Annual Biosimilar Medicines Group Conference; 28-29 April 2016; London, UK.

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