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  • Four Otezla generics were authorized simultaneously in Korea
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Apr 19, 2024 06:24am
After overcoming the patent of Amgen¡¯s original drug Otezla, which had withdrawn from the market
Amgen revokes rights for Otezla¡¯s ¡®composition and method of use¡¯ rights after withdrawing its marketing authorization in Korea
Daewoong, Dong-A, DongKoo, and CKD will immediately apply for reimbursement of their Otezla generics
 ¡ã Amgen
Four generic versions of Amgen's oral psoriasis drug Otezla (Apremilast) have been approved simultaneously in Korea.

With the resolution of Otezla¡¯s 'use patent' issue, which had served as an obstacle to the launch of generics, domestic pharmaceutical companies that have previously succeeded in avoiding the drug¡¯s composition patent seem to have applied for approval of their generic versions at once.

On the 17th, the Ministry of Food and Drug Safety approved four apremilast-based formulations, including Dong-A ST's ¡®Otelia Tab,¡¯ Daewoong Pharmaceutical's ¡®Apsola Tab,¡¯ Dongkoo Biopharm¡¯s ¡®Otemila Tab,¡¯ and Chong Kun Dang¡¯s ¡®Otebell Tab.¡¯

Otezla, the original apremilast formulation of these generic
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