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  • Atozet generic¡¯s gold rush unaffected by new regulation
  • by Lee, Tak-Sun | translator Byun Kyung A | Jan 16, 2020 06:07am
As of Jan. 13, all 21 individual bioequivalence tests approved
Regardless of saturated hyperlipidemia treatment market, follow-ons are rushing after cash cow original
The Korean pharmaceutical industry is keeping a close eye on a series of generics following MSD Korea¡¯s blockbuster combination drug for hyperlipidemia, Atozet (ezetimibe/atorvastatin calcium hydrate), in development with individual bioequivalence test, as the government has enforced new regulation on joint bioequivalence test.

Despite the already-saturated statin-ezetimibe combination drug market and increased cost of developing generic with individual bioequivalence test, the industry experts analyze the industry¡¯s needs for the hyperlipidemia treatment generic is still high.

According to Ministry of Food and Drug Safety (MFDS) on Jan 13, total 21 cases of bioequivalence test protocols have been cleared
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