Development of Iranian guidelines for ‘biogenerics’

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The national regulatory authority for approval of medicines in Iran, the Iranian Food and Drug Organization (FDO), has issued its new guidelines for registration of biologicals (recombinant medicines and monoclonal antibodies) in Iran. The guideline which was published online on 15 March 2014 describes the requirements for registration of both imported and locally manufactured biopharmaceuticals into the Iranian pharmaceutical market.

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According to a parliamentary law, medicinal products, including biological medicines, should be registered by the FDO before they can be manufactured, imported, exported, advertised, sold or distributed in the country [1].

In the past decade some national science-based pharmaceutical companies in Iran succeeded in the production of several clinically important biologicals [2], some of which still have patent protection in other countries. 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’.

The guideline defines a biogeneric as a medicine that demonstrates similarity in terms of quality, safety and efficacy to a reference brand-name biological product registered either by the US Food and Drug Administration (FDA) or European Medicines Agency (EMA).

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

Reported by Professor Majid Cheraghali, Member of International Editorial Advisory Board, GaBI Journal.

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

References
1. Cheraghali, AM. Current status of biopharmaceuticals in Iran’s pharmaceutical market. Generics and Biosimilars Initiative Journal (GaBI Journal) 2013;2(1):26-9. doi: 10.5639/gabij.2013.0201.008
2. Cheraghali, AM. Biosimilars; a unique opportunity for Iran national health sector and national pharmaceutical industry. Daru. 2012;20(1):35.

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Source: FDO

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