What Can Korea Learn From The Invossa Trial And Error Case?
South Korea, which has recently delayed the political passage of a cutting-edge regenerative medicine and biologics act, should learn from the latest unprecedented incident involving Kolon Life Science’s cell and gene therapy Invossa, and pre-emptively make preparations and guidelines to better deal with such pioneering medicines, an industry expert tells Scrip.
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The South Korean pharma/biotech industry suffered a series of negative blows in 2019 but there were still notable achievements including major drug approvals and large-scale licensing deals.
While the eventual fate of Kolon Life’s gene therapy Invossa is still undecided after interim results from an ongoing probe into its composition, controversy over the product is growing as patients seek compensation from the company and government, and calls grow for a wider investigation.
South Korea is set to adopt fast-track review systems for cutting-edge biologics and medical devices late this year as it continues to nurture the biotech industry and in line with global trends