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Iran approves its first rituximab biogeneric Posted 15/05/2015

In May 2015, Iran’s National Regulatory Authority, the Food and Drug Organization (FDO), approved its first rituximab biogeneric (Zytux). The medicine received its marketing authorization based on the previously published national guideline for marketing of biogenerics in Iran [1].

The marketing authorization is based mainly on the development of the biogeneric by comparability. The comparability data was evaluated to demonstrate the similarity between Zytux and the comparator originator drug MabThera (rituximab).

Zytux is a genetically engineered human–mouse chimeric monoclonal antibody produced by Chinese Hamster Ovary (CHO) cells in suspension and purified by chromatography. It is a fusion of the light and heavy chain variable domains of a murine monoclonal anti-CD20 antibody and human kappa light-chain and gamma 1 heavy-chain constant regions. Zytux has been approved for the treatment of cancerous lymphocytic cells and is supplied as a sterile, clear, colourless, preservative-free liquid concentrate for intravenous infusion. It is provided in two dosages, 100 mg and 500 mg vials.

Although there are already other brand-name versions of rituximab available in Iran’s market, due to its substantial lower price, it is expected that Zytux will gain a substantial share of the market. The prices of locally manufactured biologicals in Iran are between 27–72% lower than their corresponding imported originator brand-name biologicals [2].

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.

Related article
Iranian guidelines for ‘biogenerics’

Access to alternative biopharmaceuticals in low- and middle-income countries

References
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 15]. Available from: www.gabionline.net/Guidelines/Development-of-Iranian-guidelines-for-biogenerics 
2.    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

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Source: FDO

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