Academia Sinica president Wong Chi-huey (翁啟惠) yesterday said Taiwan should set up a research platform to study glycosylation of new drugs produced by local pharmaceutical companies, a move that could help the companies receive drug approvals from the US Food and Drug Administration (FDA).
The Executive Yuan’s Board of Science and Technology (BOST) accepted Wong’s suggestion as one of the conclusions of the three-day Bio Taiwan Committee seminar that ended yesterday. The conclusions will become policy guidelines once approved by the Cabinet.
Wong said companies filing drug applications to the US FDA need to provide information on the glycosylation process of their drugs for review, but most companies do not possess the capability to analyze it.
Therefore, the government should invite the state-funded Development Center for Biotechnology (DCB) and other research institutes to set up a platform to provide the service to local companies, he said.
The understanding of the glycosylation process is crucial to ascertain the effectiveness of biosimilars, which are drugs produced by living organisms, Wong said, adding that biosimiliars are gradually replacing small molecule drugs made up of a chemically based compound to become the main source of new drugs.
The Ministry of Economic Affairs said in the seminar that it has agreed to make biosimiliars the focus of the local pharmaceutical industry, aiming to help local companies launch the first biosimiliar in Taiwan in the near future.
“Since the government cannot spend as much money on biotechnology as China and South Korea, Taiwan should organize our resources more efficiently to compete,” Wong said, citing the South Korean government’s plans to invest US$9 billion in new drug development starting this year to complete the development of 20 new drugs within five years.
However, Wong said he is still optimistic about the local biotechnology industry because about 90 new drugs are undergoing clinical trials.
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