FDO issued a guideline regarding the regulation of ‘biogeneric’ products in January 2014. The FDO guideline is an overarching guideline covering general considerations for ‘biogenerics’ approval such as quality, production process, characterization, accepted limits, analytical methods, stability, non-clinical and clinical assessments, as well as pharmacovigilance and prescription and labelling information.

Although the FDO guideline is mainly an adaptation of the guideline published by the World Health Organization (WHO), alongside some small differences between the two guidelines it seems that Iran is the first country, which has named its locally manufactured biologicals as ‘biogeneric’ [1].

1. Overarching Guideline
This guideline covers all ‘biogeneric’ products:

Guideline for ‘biogeneric’ products
Date: 11 January 2010
http://fdo.behdasht.gov.ir/index.aspx?siteid=114&pageid=40850&siteid=114

The guideline, which is in the local language (Farsi), is available from the FDO website (http://fdo.behdasht.gov.ir/).

The guideline defines ‘biogenerics’ as products that refer to biological products that have the same active substance with the original brand and in terms of quality; safety and efficacy are similar to the innovator and are capable of replacing it for therapeutic purposes. Due to the molecular largeness and complexity, proving therapeutic equality of the drugs is carried out through preclinical and clinical studies.

The guideline also specifies that if the reference product has not been registered in Iran a reference product authorized by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) may be selected as a reference product.

Editor’s comment
It should be noted that ‘biogenerics’ approved in Iran might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Note: According to Professor Cheraghali, the term ‘biogeneric’ is the official term used by Iran’s FDO both in Farsi and English.

Related articles

First biogeneric for Iran

EU guidelines for biosimilars

 US guidelines for biosimilars

Reference

1. GaBI Online - Generics and Biosimilars Initiative. Development of Iranian guidelines for ‘biogenerics’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www.gabionline.net/Guidelines/Development-of-Iranian-guidelines-for-biogenerics

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