Chong Kun Dang drug gets Japan green light

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Chong Kun Dang drug gets Japan green light

Chong Kun Dang Pharmaceutical won approval to sell its first biosimilar in Japan, a major win for a company that has been trying to increase its presence in the global biopharmaceutical market.

The Korean biopharmaceutical company announced Tuesday that Japan’s Ministry of Health, Labor and Welfare authorized the sale of Chong Kun Dang’s first biosimilar Nesbell, which is based on Kyowa Hakko Kirin’s anemia treatment Nesp.

Biosimilars are biological products that are approved based on proof that they are highly similar to other previously approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.

As a part of an agreement made in April 2018, Chong Kun Dang is going to sell Nesbell to the Japanese unit of United States-based Mylan N.V., which will be in charge of launching and distributing the product in the country by December.

Nesbell is already on the shelves in Korea after winning approval from the Ministry of Food and Drug Safety last December.

“Nesbell is the world’s first Nesp biosimilar and Chong Kun Dang’s first biopharmaceutical product, so this latest approval for manufacturing and selling it in Japan means a lot to the company,” a Chong Kun Dang spokesperson said. “Starting with a Japanese market worth 550 billion won [$459 million], we will work to launch our product on the global market, which is 3.6 trillion won in size.”

Chong Kun Dang started developing the biosimilar in 2008 when the company acquired key manufacturing technology. The company is attempting to win more approvals in other countries after it acquired patents for the manufacturing technology from nine countries.

Chong Kun Dang is conducting Phase 3 clinical trials for CKD-701, a biosimilar based on Novartis’ macular degeneration treatment Lucentis, while preparing Phase 1 clinical trials for its bispecific antibody candidate CKD-702.

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