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| Celltrion's headquarters in Incheon / Courtesy of Celltrion |
Celltrion's Herzuma set to debut next year
By Park Jae-hyuk
Korean biosimilars have begun to expand their presence in the U.S. market.
Domestic pharmaceutical firms such as Celltrion and Samsung Bioepis are expected to vie with global competitors, as well as each other, with their high-quality biosimilars based on enhanced technical skills.
According to industry officials, Tuesday, the U.S. Food and Drug Administration (FDA) accepted a biologics license application (BLA) for Celltrion's cancer treatment Herzuma last week.
Herzuma is a cheaper biosimilar copy of Herceptin, which has been sold by Swiss pharmaceutical giant Roche and was developed by Roche-owned Genentech. Herceptin's global sales surpassed $7 billion last year.
Celltrion submitted the BLA for the biosimilar drug in May. After a 60-day review in accordance with the law, the FDA officially accepted the application. The final approval of the drug is expected to be made in the first half of next year.
Herzuma was approved in Korea in January 2014 and will hit the shelves toward the end of the year. Celltrion applied for licenses to sell the drug in Europe and Japan as well.
Given its Remsima, a treatment for autoimmune diseases, has been marketed in the United States under the name of Inflectra, the Incheon-based company expects to expand its presence in the world's largest pharmaceutical market.
As the first Korean biosimilar approved in the U.S., Remsima has increased its market share since last December, according to the company. The application for Truxima, another Celltrion biosimilar, has been accepted by FDA as well.
"We will try our best to offer treatments to more patients in the U.S.," Celltrion CEO Kee Woo-sung was quoted as saying. The firm also said its Herzuma will be distributed there by global pharmaceutical firm Teva.
In addition to Celltrion, Samsung Bioepis has begun to tap into the U.S. market.
Its biosimilar drug Renflexis was also launched in the U.S. last week following the approval of FDA three months ago. The immunology medicine is a biosimilar copy of Janssen Biotech's blockbuster Remicade.
Renflexis has been marketed by Samsung Bioepis's global partner Merck & Co. at a wholesale acquisition price of $753.39, 35 percent cheaper than the current listing price of Remicade.
"Samsung Bioepis has been able to rank with global pharmaceutical giants in the world's largest market following the launch of Renflexis," Samsung Bioepis CEO Ko Han-sung said in a statement. "We expect more patients will benefit from the drug."
Meanwhile, Celltrion founder Seo Jung-jin has become the nation's 10th richest stockholder, thanks to the achievement of the biosimilars. He is the second self-made figure to be included in the top 10 list, along with Netmarble Games chief Bang Joon-hyuk.
According to Chaebul.com, Seo held shares worth 2.4 trillion won ($2.13 billion) as of last week, after Celltrion Healthcare was listed on the KOSDAQ market.
Both Celltrion and Celltrion Healthcare were established by Seo. While the former develops biosimilars, the latter exclusively ships the drugs overseas.
