As part of a project to build the first biosimilar factory in Malaysia, one of the initial products would be halal certified.
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.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs
March 29th 2024Despite more biosimilars entering the market and generating significant savings for payers and health care systems, these savings are not resulting in lower out-of-pocket (OOP) costs for patients, according to a recent study.