First biogeneric for Iran

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First biogeneric for Iran

Biosimilares/Novedades | Posted 23/05/2014 0 Post your comment

Iran has developed the country’s first ‘biogeneric’ drug for cancer patients. The announcement was made in the presence of Iran’s Deputy Health Minister Hassan Hashemia at the beginning of February 2014, according to a report in the Tehran Times.

The drug, which has been named Pegajen, is a biogeneric of pegfilgrastim, a pegylated form of recombinant human granulocyte colony-stimulating factor (G-CSF). Pegfilgrastim stimulates the bone marrow to increase neutrophil (white blood cell) production and can be used to fight infection in immunocompromised patients undergoing chemotherapy.

Iran’s Government has allocated substantial resources to support local drug companies who manufacture biologicals [1]. However, because drug companies in the country have not had access to the same manufacturing facilities and processes as those used to produce originator drugs, they have been unable to claim similarity between their copies and the originator brands. This is likely to change with ongoing improvements being made within Iran’s pharmaceuticals industry.

Amgen currently manufactures pegfilgrastim under the brand name Neulasta. The drug will lose its patent protection for this US$4 billion a year drug in October 2015 for the US and in August 2017 for Europe [2].

Because Iran is not currently a member of the World Trade Organization, the country’s national laws and regulations for the protection of patents and brands registered by Iranian companies inside Iran do not apply to foreign companies [1]. If Iranian drug companies have access to the same manufacturing processes as those used to produce originators, they will be able to manufacture both patented and off‑patent biologicals.

Iran already manufactures many of its own cancer drugs. In July 2013, the Deputy Head of the country’s Organization for Food and Drugs of the Ministry of Health, Shamsali Rezazade, announced that Iran was producing the chemotherapy drug, docetaxel. Previously, the country relied on overseas imports.

All stages of Pegajen drug production will be carried out in Iran.

Editor’s comment
It should be noted that biogeneric approved in Iran might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Readers interested to learn more about biologicals in Iran are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Current status of Biopharmaceuticals in the Iran Pharmaceutical Market

Note: According to Professor Cheraghali, member of International Editorial Advisory Board, GaBI Journal; the term ‘biogeneric’ is the official term used by Iran’s FDO both in Farsi and English.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Significance of locally produced biosimilars in Iran [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 23]. Available from: www.gabionline.net/Biosimilars/Research/Significance-of-locally-produced-biosimilars-in-Iran
2. GaBI Online - Generics and Biosimilars Initiative. Biologicals sales have almost doubled since 2006 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 23]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-sales-have-almost-doubled-since-2006

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Source: Haberler, Mehr News, Tehran Times