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Biosimilar production in Malaysia Posted 25/09/2015

Malaysian biotech firm Inno Bio Ventures has announced the signing of a memorandum of understanding (MoU) with Iranian firm Aryogen Biopharma. The agreement will lead to the production of the first Malaysian-made biosimilars for the local and regional market.

Inno Bio Ventures says that the two companies will now have exclusive rights to market four products across the Asean region, which includes Cambodia, Laos, Myanmar, the Philippines and Vietnam.

The following four products are reported to be involved in the MoU: etanercept; rituximab; trastuzumab and factor VII for haemophilia and congenital factor VII deficiency.

Biosimilars, dominated by global pharma players, have been forecast to expand at a compounded average growth rate of 12% in Asia to an estimated eight billion Malaysian Ringgit (equivalent to Euros 1.65 billion) in the Southeast Asian region by 2020 [1]. Generics manufacturing, prescribing and sales are becoming firmly part of the scene in Malaysia [2].

The Iranian pharmaceutical industry was last mentioned in GaBI Online in 2013, when Professor Abdol Majid Cheraghali*, wrote that Iran’s pharmaceutical industry did not have access to the production procedures of originators, including cell type, fermentation and purification procedures. For this reason, said Cheraghali, Professor of Pharmacology and Toxicology at the University of Baqiyatallah Medical Sciences, Tehran, Iran, companies could not claim ‘similarity’ to originator brands [3].

Copied biopharmaceuticals including granulocyte colony-stimulating factors, human growth hormones and interferons may have received marketing authorization for the local Iranian market, but – at that time – none had received evaluation according to internationally recognized guidelines for biosimilars.

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

1. GaBI Online - Generics and Biosimilars Initiative. Asian companies venture into biosimilars for kidney failure [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 25]. Available from: www.gabionline.net/Biosimilars/News/Asian-companies-venture-into-biosimilars-for-kidney-failure
2. GaBI Online - Generics and Biosimilars Initiative. Generics have their feet under the table in Malaysia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 25]. Available from: www.gabionline.net/Generics/General/Generics-have-their-feet-under-the-table-in-Malaysia
3. 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 

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Source: Inno Bio Ventures, The Star

Comments (2)

Response to 'Creative Peptides' posted 10/11/2015 - by Julie S, GaBI Online Editorial Office

Dear Sirs, Thank you for your interesting comment on this article. We appreciate that you are sharing your thoughts on this subject with us. Please feel free to reach us at editorial@gabi-journal.net with any more of your thoughts. Thank you again and we hope to hear from you soon.

Comment posted 22/10/2015 - by Creative Peptides

The medical market is becoming wider and wider. I think most developing countries should stress the development of biotech, just like Malaysia. Health issues are always the public concerns.

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