Biopharmaceutical products in Iran

Biosimilares/Investigación | Posted 31/05/2013 post-comment2 Post your comment

Iran will become a leader in biotechnology products (especially copied biopharmaceuticals [1]) in Asia over the next three years, according to a review by Mahboudi et al. [2].

Iran flag V13E31

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

Product name* Active ingredient Therapeutic area Company Reference product Originator company
AryoSeven anti-haemophilic factor VII (human) Haemophilia
Von Willebrand disease
AryoGen Alphanate/ Hemofil M/ Koate-DVI/ Monoclate-P Grifols/
Baxter/
Kedrion Biopharma
Arvestin bevacizumab Cancer AryoGen Avastin Roche
CinnaFact Buserelin acetate Advanced prostate cancer (stage D)
Endometriosis
CinnaGen Suprefact sanofi-aventis
Epolyrec epoetin alpha Anaemia
Cancer
Chronic kidney failure
Pasteur Institute of Iran
Poyesh Daro
Recpharma
Erypo Janssen-Cilag
Betapoietin epoetin beta Anaemia
Autologous blood transfusion
Cancer
Chronic kidney failure
CinnaGen Zahravi Neorecormon Roche
Altebrel etanercept Arthritis
Psoriasis
AryoGen Enbrel Pfizer
PDgrastim filgrastim Cancer
Hematopoietic stem cell transplantation
Neutropenia
Poyesh Daro Neupogen Amgen
  hepatitis B vaccine Hepatitis B Pasteur Institute of Iran Recombivax HB/
Engerix-B
Merck/GSK
PDferon-B interferon alpha Antitumour
Chronic hepatitis C
Leukaemia
Pasteur Institute of Iran
Poyesh Daro
IntronA Merck Sharp & Dohme
Cinno Vex interferon beta 1a Multiple sclerosis CinnaGen Avonex/Rebif Biogen Idec/ Merck Serono
ReciGen interferon beta 1a Multiple sclerosis CinnaGen Avonex/Rebif Biogen Idec/ Merck Serono
Ziferon interferon beta 1b Multiple sclerosis Zistdaru Danesh Betaferon/ Betaseron/ Extavia Bayer Healthcare/ Novartis
Immunex interferon gamma Chronic granulomatous disease (CGD)
Severe, malignant osteopetrosis
Recpharma Actimmune Vidara Therapeutics
Cinno Par parathyroid hormone Osteoporosis CinnaGen Forteo Eli Lilly
Pegaferon peg-interferon alpha Chronic hepatitis C Poyesh Daro PEG-Intron Schering-Plough

Reditux/

Zitux

rituximab Rheumatoid arthritis
Non-Hodgkins lymphoma
Leukaemia
CinnaGen/AryoGen MabThera Roche
Hebreastin trastuzumab Stomach neoplasms
Breast neoplasms
AryoGen Herceptin Roche
*product names given where available

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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comment icon Comments (2)
Post your comment
Posted 03/06/2013 by Jodi H, GaBI Online Editorial Office
Response to 'Biopharmaceutical products in Iran'

Dear Professor Cheraghali,
Thank you for your comment. Please note that we referenced your paper for the term ‘copied pharmaceuticals‘.
Best regards, Jodi

Posted 02/06/2013 by N/A
Biopharmaceutical products in Iran

"Iran produces 95% of its medicines locally, of which 5% are biosimilars [1, 3]."
Dear Editor
Since these are wrong information and Iran does not produce such share of its pharmaceutical market locally and I have never cited such data in my published paper in GaBi I would appreciate if you revise this mistake in the commentary.
Regards
Prof. Abdol Majid Cheraghali

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