The purpose of the International Pharmaceutical Regulators Forum (IPRF) is to create an environment for pharmaceutical regulators to exchange information on issues of mutual concern and to foster regulatory cooperation. The organization’s Biosimilars Working Group (BWG) is one of five working groups that have been established to address specific issues.
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 the role of the IPRF’s BWG and some of the initiatives it has taken so far in the area of biosimilars.
The group’s work plan and mandate were adopted in June 2015. It subsequently released a template for Public Assessment Summary Information for Biosimilars (PASIB). PASIB is an optional tool. The BWG proposes that PASIB be used in order to increase transparency and to ease the transition between the local language and English [2], thus reducing local translation efforts by the national regulatory authority (NRA).
PASIB includes key information and summarized details of the biosimilar review and is expected to be of more use to countries that currently do not publish their reviews or do so only in a local language that is not English. The IPRF published the proposed template as well as instructions on how to complete the form and four completed examples.
PASIB can be used for the lifecycle of the biosimilar. The NRA may ask the applicant to compile the data required for PASIB. The idea is that the NRA should decide how best to use PASIB. The NRA is then expected to compile the review summary and control the final document. While the NRA remains free to compile the review summary as required, the IPRF encourages consistency and transparency and advocates that NRAs aim to keep the summary to less than 10 pages.
The IPRF aims to provide directory via its website, which would include PASIB from the local NRA, as well as European Public Assessment Reports (EPARs) and other assessment report formats.
In July 2016, the IPRF released a draft reflection paper on the extrapolation of indications in the authorization of biosimilars [3]. The draft reflection paper suggests that authorization of biosimilars be carried out using a stepwise approach and that extrapolation of indications can be accepted based on the ‘totality of evidence’.
The BWG also aims to enable a smoother synergy with World Health Organization (WHO) and to carry out training in the area of biosimilars.
Editor’s comment
Readers interested to learn more about transparency for biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Roundtable on biosimilars with European regulators and medical societies
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If you would like to receive a PDF copy* of the Richardson presentation [1], please send us an email.
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References
1. Richardson P. EMA Biosimilar update: International Regulatory Convergence. 14th Annual Biosimilar Medicines Group Conference; 28-29 April 2016; London, UK.
2. GaBI Online - Generics and Biosimilars Initiative. IPRF template for summary information for biosimilar reviews [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 11]. Available from: www.gabionline.net/Biosimilars/General/IPRF-template-for-summary-information-for-biosimilar-reviews
3. GaBI Online - Generics and Biosimilars Initiative. IPRF issues draft reflection paper for biosimilars extrapolation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 11]. Available from: www.gabionline.net/Guidelines/IPRF-issues-draft-reflection-paper-for-biosimilars-extrapolation
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