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Madopar triggers bioequivalence test verification requests

By Lee, Hye-Kyung | translator Kim, Jung-Ju

23.09.23 05:50:39

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MFDS ¡®has conducted bioequivalence tests with the original drug¡¦ approved generics are deemed equivalent in terms of safety and efficacy.¡¯



The demand has been rising for the government to verify the validity of bioequivalence tests conducted by generic versions of Madopar Tab (levodopa-benserazide), Roche Korea¡¯s Parkinson's disease drug that had withdrawn from the domestic market.

Opinions are being collected on the post ¡®Regarding the validity of bioequivalence tests that serve as the standard for approving generic drugs¡¯ that appeared as an open petition on the Petition24 website earlier this month. The opinion collection deadline is October 6.

The petitioner, who described himself as a Parkinson's disease patient for 20 years, said, "Original drug manufacturers are withdrawing from Korea because of fake generic drugs

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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