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World First Korea Darbepoetin Biosimilar Approval To Speed CKD's Global Entry?

 
• By Jung Won Shin

With a global first marketing authorization for its darbepoetin biosimilar in South Korea, Chong Kun Dang aims to speed up the product’s entry into the Japanese and other international markets and progress clinical rials with other biosimilars and novel biologics.

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CKD Get's World First Biosimilar Darbepoetin Approval • Source: Shutterstock

Chong Kun Dang Pharmaceutical Corp. (CKD) has received marketing authorization for its biosimilar darbepoetin alfa from South Korea's Ministry of Food and Drug Safety, marking further progress towards the product’s global entry following its recent regulatory approval filing in Japan.

The approval of Nesbell (CKD-11101), the South Korean pharma’s first in-house developed biological drug, was also the world’s first nod for a biosimilar version of Amgen Inc.'s Nesp/Aranesp

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