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Korea Mulls New Biosimilar Guidelines As Pipeline Surges

This article was originally published in PharmAsia News

Executive Summary

As more biosimilar products are set to be released in South Korea, with a hefty number of ongoing late-stage clinical trials, the country is seeking to introduce a new separate guideline for insulin biosimilars. While South Korea has introduced biosimilar guidelines relatively earlier than some others, a local institute suggests these still need to be improved, pointing to a lack of clarity and implementation issues.

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