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  • Reinforced drug regulations change generic drug approvals
  • by Chon, Seung-Hyun | translator Alice Kang | Jan 9, 2023 06:10am
The number of generic drugs approved per bioequivalence tests falls drastically with reinforced regulations
No of drugs approved through bioequivalence tests reach 648 in 2021... 73% less than those compared to 2 years ago
No of approved generic drugs fall after drug pricing restructuring...number of consigned generic drugs fall drastically
The number of generic drugs approved per every bioequivalence test fell greatly. Affected by the reform made in Korea's drug pricing policy, the proportion of generic drugs approved per bioequivalence test dropped significantly.

According to the Food & Drug Statistical Year Book published by the Ministry of Food and Drug Safety on the 6th, 648 items were approved after being recognized as bioequivalent to their alternative in 2021. This was a 58.8% decrease from the 1,573 approved in 2020. Compared to the 2,358 in 2019, this was a 72.5% decrease in 2 years.

Drugs recognized as bioequivalent are products recognized as being equivalent to their original drug, and are mostly granted for newly approved generic drugs.
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