Biopharmaceutical products in Iran

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

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.

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. 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. 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.

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

Source: www.gabionline.net

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