Pangen said Thursday that Malaysia’s National Pharmaceutical Regulatory Agency has granted sales approval for Erisa, an epoetin alfa (EPO) biosimilar.
Erisa is a biosimilar used for treating anemia in patients with chronic renal failure. The company developed the product with CCM Duopharma, a state-owned Malaysian pharmaceutical company, and had conducted phase 3 clinical trials in both countries before the approval.
EPO, first developed by Amgen, has only one biosimilar developed by Sandoz in 2007. With the approval, Pangen has become the second company to launch a biosimilar for EPO.
According to the company, the global EPO market, which was worth 8 trillion won ($7.1 billion) in 2016, is continuing to expand into emerging markets.
As CCM Duopharma codeveloped the product with Pangen, the company has exclusive rights to Malaysia, Singapore and Brunei markets. CCM Duopharma plans to start marketing the drug from April.
The two companies are also pioneering other ASEAN markets. Pangen has signed deals in Thailand and Turkey, and is in talks with Saudi Arabia and the Middle East.