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  • Issues to remain as restricting bioequivalence test scrapped
  • by Lee, Tak-Sun | translator Byun Kyung A | Apr 29, 2020 06:19am
Issues of preferential sales approval on multiple generics to remain
Despite pricing benefit for generic with individual test data, high demand for first generic won¡¯t die out
The issues regarding highly saturated first generic market would likely to remain as the Regulatory Reform Committee has axed the Korea Ministry of Food and Drug Safety¡¯s (MFDS) plan to restrict joint and cosigned bioequivalence test.

Even if the government grants favorable pricing on generics with individual test data from July, the industry experts expect that many of pharmaceutical companies would still choose to run joint bioequivalence tests to not miss out on their market release timing.

Accordingly, pharmaceutical companies can now save much on their R&D and production costs like on pharmaceutical research and bioequivalence test. But the issues of pharmacy and primary consumer¡¯s difficulty in product
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