CCMD said on Friday if the trials, starting in November are successful, it will have the commercialisation rights to market and distribute the drug in Malaysia, Singapore and Brunei, worth more than RM50mil annually.
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PDA10, or Epoetin-Alfa, is PanGen’s first commercial finished "biosimilar" – that is, a follow-on version of existing bio-pharmaceutical product whose patent has expired.
The clinical trial costing RM8mil involves 18 sites and 300 patients in Malaysia, while in Korea, where testing is already underway, it includes five sites and 40 patients.
To recap, the trial follows the joint clinical trial agreement with PanGen in June 2012. The trial will conform with the European Medicines Agency and the Malaysian National Pharmaceutical Control Bureau (NPCB) guidelines.
“This agreement will enable CCMD and CCM Group to compete for high value added partnership projects in the commercialisation of biosimilars while eliminating the need to invest in very expensive clinical trials and long gestation periods to deliver the product to market,” said Amirul Feisal, a CCMD board member.
Biosimilars, dominated by global pharmaceutical players, is forecast to expand at a compounded average growth rate of 12% in Asia, and is expected to be worth an estimated RM8bil in Southeast Asia by 2020.
CCMD invested RM7mil to establish Malaysia’s first NPCB-certified GMP Biological Fill and Finish facility in Klang and it might invest an additional RM9mil for a pre-filled syringe suite should the phase three trials prove successful.
Source: theSTAR 01-11-2013
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