Mycenax also announced that TuNEX would undergo a phase III clinical trial soon, with plans to also undertake multinational, multicenter phase III studies in several countries such as Korea and India, using the clinical data obtained to apply to market the drug in other locations globally.

With the completion of the phase I trial in Korea – a 'biosimilar' as stipulated by Korean drug approval regulations, conducted on 24 healthy patients at National Seoul University – TuNEX becomes the first protein drug developed in Taiwan to pass such a milestone overseas.

The Taiwan clinical trial – a 'new drug' as stipulated by Taiwan drug approval regulations –was completed in September 2009 on 18 arthritis patients at the Taichung Veteran General Hospital, Kaohsiung Veteran General Hospital and Buddhist Tzu Chi General Hospital. The final report will be completed at the end of 2009, reported Dr Karen Wen, spokesperson and Vice President at Mycenax.

Dr Michael Hwang, Mycenax Founder and President said, “With TuNEX being an INN etanercept biosimilar to Enbrel, the world's largest biological pharmaceutical with over US$6 billion (Euros 4.04 billion) in sales, we expect that TuNEX will become a successful, popular cost-effective alternative.”

The development of Taiwan's first biosimilar is also welcome news for the country's fledgling biotech sector.

“With the drug ready to enter phase III trials, it’s indicative of the strength and potential of the biotechnology industry in Taiwan that a small company [50 employees] can produce and develop such an international class drug and compete on global markets,” Dr Hwang said.

Reference:
Biosimilar TuNEX® from Mycenax completes phase I/II clinical trial in Taiwan, phase I in Korea. Taiwan News. 2009 Oct 20.