World's First Halal Biosimilar to Be Produced in Malaysia

Production of the world's first halal biosimilar, which would mean a biologic permissible under Islamic law, would be a feature of expanded commercial biosimilar production in Malaysia, officials involved in the deal said.

The plans include construction of a commercial biosimilar production center in Malaysia, although an exact location for this facility has yet to be determined. The project involves a collaboration with the government-backed investment company VentureTECH, Malaysia-based Duopharma Biotech Bhd, and Republic of Korea—based PanGen Biotech. Construction would be completed by 2024, the reports from the corporate officials involved and The Edge Markets and Malaysia Gazette said.

Officials were quoted as saying that for Malaysia, expanding the local biologics industry is a costly undertaking, but this will be made easier by taking the biosimilar route because far less investigative development is required.

VentureTECH would invest capital in the enterprise and biosimilars would be produced for both the export and domestic markets, the official statement said.

One of the products to be produced in the new plant would be PanGen’s epoetin alfa biosimilar (Erisa, Erysaa), and this would be halal certified, according to the statement. "DuoPharma Biotech and PanGen have successfully developed biosimilar erythropoeitin ... resulting in the establishment of the [memorandum of understanding] aimed at building local capacity to produce (Erysaa) and other biosimilar products," the statement said. This product has been certified as halal by the Korean Muslim Federation and is under review by Jabatan Kemajuan Islam Malaysia for halal certification in Malaysia, they said.

Epoetin alfa stimulates erythropoiesis, or an increase in red blood cells, and is used to treat anemia.

Duopharma Biotech manufactures, imports, and exports pharmaceutical products. The company has commercialized Erysaa and also, recently, a trastuzumab biosimilar (Zuhera). The company obtained halal certification for Erysaa from the Korean Muslim Federation to qualify for product launch in Malaysia. The company said in a recent statement that this was the first halal certification for any biosimilar anywhere in the world.

“We are motivated to grow the halal pharmaceutical segment both because of the huge business potential it presents, and because we believe in offering Muslims, and indeed all discerning consumers of all faiths, a peace of mind knowing they can avail of the best medical treatments that are halal certified,” Leonard Ariff Abdul Shatar, group managing director of Duopharma Biotech, said in a June company statement.

The company said 95% of its products are halal certified.

The company has a production line in its Klang, Malaysia, factory that has been approved for production of Erysaa, and that operation has been under expansion to handle higher volumne Erysaa production.

PanGen specializes in the develop of new biologics and biosimilar products.

In April, Biocon announced that it had received FDA clearance for production of insulin glargine (Semglee) at its new Malaysia plant. This came after the company received Complete Response Letters and Form 483 notices, which are FDA statements that production cannot begin until improvements are made.