Malaysia-based manufacturer Duopharma Biotech aims to establish Malaysia’s first commercial biosimilar production facility. The company is also working to achieve halal certification for its erythropoietin biosimilar, Erysaa.
Medicine manufacturer Duopharma Biotech aims to start producing biosimilars in its home country Malaysia. In July 2020, Duopharma signed an agreement with government investment body VentureTech and Korean firm PanGen to establish the country’s first commercial biosimilar production facility. VentureTech will invest US$3.6 million in the project, which is expected to complete in 2024.
Of the deal, Duopharma Managing Director Leonard Ariff bin Abdul Shatar told the website Salaam Gateway: ‘The new plant means venturing into new therapeutic areas and providing halal options for the Muslim market and for everyone else’.
One of Duopharma’s major products is biosimilar erythropoietin (sold as Erysaa), which is co-developed with PanGen. Erythropoietin stimulates the production of red blood cells and is used to treat anaemia in conditions such as chronic kidney disease. Erysaa was approved by Malaysia’s National Pharmaceutical Regulatory Agency in February 2019 [1].
Erysaa has already been certified as halal in Korea and is currently being assessed by the Malaysian certification body, JAKIM. However, there has been some delay in Malaysian certification due to differences in the interpretation of the use of Chinese hamster ovary (CHO) cells. CHO cells are often used to produce recombinant proteins, including erythropoietin.
The fact that CHO cells are used in the production of Erysaa means JAKIM have not yet been able to certify the product as halal, as the Malaysian authorities closely follow the Shafiʽi school of Islamic jurisprudence.
‘There are various other considerations over whether the animal itself was used, or only a part of it, such as the epithelial cells; that the animal was produced in a sterile laboratory environment and not in the wild; that it is not consumed as food, and only a part of its cells was used in the process of producing the erythropoietin’, explained Duopharma’s Managing Director.
The company says it needs to overcome this challenge in order to progress in the biosimilars space in Malaysia.
Malaysia’s halal pharmaceutical exports exceeded US$95 million in 2019. The country’s halal pharmaceutical standards have recently been expanded to include biologicals and vaccines, facilitating the acceptance of halal pharmaceuticals produced in Malaysia elsewhere in the world.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. PanGen gains Malaysian approval for epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 11]. Available from: www.gabionline.net/Biosimilars/News/PanGen-gains-Malaysian-approval-for-epoetin-alfa-biosimilar
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