Over the last two decades the Iranian biotechnology sector has evolved through a number of scattered and sporadic academic and industrial initiatives. Policies to encourage the advancement of biotechnology as a successful industry are now more organized and come under the jurisdiction of the Ministry of Science, Research and Technology; the Ministry of Health and Medical Education, Deputy of Research and Technology and the Center for Cooperation of Science Technology and Innovation.

Since the end of its war with Iraq in 1988, Iran has invested in education and research, and now boasts more than 15 biotechnology research centres and departments operating in medical universities. Iran produces 95% of its medicines locally, of which 5% are copied biopharmaceuticals [3].

In order to support and encourage local manufacturing of biopharmaceuticals, Iran’s Ministry of Health and Medical Education has also approved regulations for ‘copied biopharmaceutical products’ as they are referred to in Iran [2]. This has led to the approval of 17 copied biopharmaceutical products, see Table 1, with at least 15 further products in the pipeline, which are expected to be approved in the next three years.

Table 1: Copied biopharmaceutical products approved in Iran

Considering the number of copied biopharmaceutical products approved or in the pipeline, Mahboudi et al. [2] believe that Iran is well placed to become ‘one of the biggest biosimilar producers in the world’ and will lead Asia in the number of products.

Editor’s comment
According to Professor Majid Cheragali*, Iran’s pharmaceutical industry does not have access to the production procedures of originators, including cell type, fermentation and purification procedures, they cannot claim ‘similarity’ to originator brands. These copied biopharmaceuticals including granulocyte colony-stimulating factors, human growth hormones, interferons, have received marketing authorization for the local Iranian market, but none have received evaluation according to internationally recognized guidelines for biosimilars [1].

*Professor Majid Cheragali is a member of the International Editorial Advisory Board of GaBI Journal.

Related article

Significance of locally produced biosimilars in Iran 

References

1.  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.  Mahboudi F, Hamedifar H, Aghajani H. Medical biotechnology trends and achievements in Iran. Avicenna J Med Biotechnol. 2012 Oct;4(4):200-5.

3.  GaBI Online - Generics and Biosimilars Initiative. Production of 24 biogeneric products in Iran by 2012 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 May 31]. Available from: www.gabionline.net/Biosimilars/News/Production-of-24-biogeneric-products-in-Iran-by-2012

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