PanGen gains Malaysian approval for epoetin alfa biosimilar

Biosimilars/News | Posted 15/02/2019 post-comment0 Post your comment

South Korea-based biotechnology company PanGen Biotech (PanGen) announced on 7 February 2019 that Malaysia’s National Pharmaceutical Regulatory Agency has granted sales approval for Erisa, an epoetin alfa biosimilar.

Erythropoietin V13F07

Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

PanGen made a deal with Malaysia-based Chemical Company of Malaysia Berhad (CCM), wholly owned subsidiary of CCM Duopharma Biotech Berhad, to carry out a clinical trial of biosimilar erythropoietin in Malaysia to treat end-stage renal failure patients [1]. Since CCM Duopharma co-developed the product with PanGen, the company has exclusive rights to the Malaysia, Singapore and Brunei markets. CCM Duopharma plans to start marketing the drug as of April 2019. The two companies are also targeting other ASEAN (Association of Southeast Asian Nations) markets. PanGen has signed deals in Thailand and Turkey, and is in talks with Saudi Arabia and the Middle East.

According to its biosimilar pipeline, PanGen has submitted an application for approval of its epoetin alfa biosimilar (PDA10) in South Korea, and is also working on biosimilars of Factor VIII (PGA40) and granulocyte colony-stimulating factor (G-CSF) (PHA30).

There are already three epoetin alfa and two epoetin zeta biosimilars approved in the European Union. Retacrit and Silapo (epoetin zeta), as well as Abseamed, Binocrit and Epoetin alfa Hexal (epoetin alfa), were all approved in 2007. One epoetin alfa biosimilar, Retacrit (epoetin alfa-epbx), has also been approved in the US.

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1. GaBI Online - Generics and Biosimilars Initiative. Asian companies venture into biosimilars for kidney failure []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 15]. Available from:

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Source: Korea Biomedical Review, PanGen

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