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Celltrion’s Herzuma approved by U.S. FDA

Dec 17,2018
Celltrion’s breast cancer treatment Herzuma has been approved by the U.S. Food and Drug Administration (FDA) to start sales in the country, the bio company said Sunday.

Herzuma is a biosimilar of German pharmaceutical company Roche’s Herceptin, a breast cancer treatment that rakes in an annual revenue of 7.8 trillion won ($6.9 billion). Demand in the United States alone is estimated at 3 trillion won, according to Celltrion.

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

Herceptin’s patent in the United States expires in 2019, paving the way for biosimilars like Herzuma to launch and profit from demand. In Europe, the patent expired in 2014 and Herzuma received approval last February.

Herzuma is the last of Celltrion’s three biosimilars, after Remsima and Truxima, to be approved by the U.S. FDA. It is also the 16th FDA-approved biosimilar. This makes Celltrion one of the few firms to have three products on the list, alongside global pharmaceutical giants Novartis and Pfizer.

The achievement comes a decade after the company first started developing biosimilars in the late 2000s.

According to a Celltrion spokesman, the three biosimilars are based on treatments that have a combined market value of 14 trillion won in the United States alone.

Israel-based Teva Pharmaceutical will be in charge of Herzuma’s distribution and marketing in the United States. It also has rights to commercialize Truxima in the country.

“Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provide more patients access to this important therapy,” said Kee Woo-sung, CEO of Celltrion.


BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]