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Biopharmaceutical products in Iran Posted 31/05/2013

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].
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 AryoGen Alphanate/ Hemofil M/ Koate-DVI/ Monoclate-P
Grifols/ Arvestin bevacizumab Cancer AryoGen Avastin Roche CinnaFact Buserelin acetate
Advanced prostate cancer (stage D) CinnaGen Suprefact sanofi-aventis Epolyrec epoetin alpha
Anaemia
Pasteur Institute of Iran Erypo Janssen-Cilag Betapoietin epoetin beta
Anaemia CinnaGen Zahravi Neorecormon Roche Altebrel etanercept
Arthritis AryoGen Enbrel Pfizer PDgrastim filgrastim
Cancer Poyesh Daro Neupogen Amgen hepatitis B vaccine Hepatitis B Pasteur Institute of Iran
Recombivax HB/ Merck/GSK PDferon-B interferon alpha
Antitumour
Pasteur Institute of Iran 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) 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 CinnaGen/AryoGen MabThera Roche Hebreastin trastuzumab
Stomach 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 *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 Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing. Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.
Von Willebrand disease
Baxter/
Kedrion Biopharma
Endometriosis
Cancer
Chronic kidney failure
Poyesh Daro
Recpharma
Autologous blood transfusion
Cancer
Chronic kidney failure
Psoriasis
Hematopoietic stem cell transplantation
Neutropenia
Engerix-B
Chronic hepatitis C
Leukaemia
Poyesh Daro
Severe, malignant osteopetrosis
Non-Hodgkins lymphoma
Leukaemia
Breast neoplasms
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].
Comments (2)
Response to 'Biopharmaceutical products in Iran' posted 03/06/2013 - by Jodi H, GaBI Online Editorial Office
Dear Professor Cheraghali, Thank you for your comment. Please note that we referenced your paper for the term ‘copied pharmaceuticals‘. Best regards, JodiBiopharmaceutical products in Iran posted 02/06/2013 - by N/A
"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 CheraghaliGenerics News Research General
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