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Celltrion gets closer to marketing Herzuma in Europe

Collected: 2017.12.18

Distributed: 2017.12.19

Source: Go Direct

South Korea’s Celltrion, Inc. is one step closer to launching Herzuma (trastuzumab biosimilar) across Europe as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that the drug be granted marketing authorization in the European Union for the treatment of patients with early and metastatic breast cancer or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification.

The recommendation was made just 14 months after the company’s filing to the EMA in October of last year.

The CHMP’s opinion will now be sent to the European Commission (EC) for final review, which usually takes two to three months.

Upon final regulatory approval, the drug can be available in 28 EU members and three European Economic Area (EEA) countries. The company expects its marketing to be in full-scale in the first half of next year.

Herzuma is a biosimilar version of Herceptin, a breast cancer and gastric cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. Herceptin generated global sales of nearly $7 billion in 2016 for Roche, of which $2.1 billion was in European sales.

Herzuma, the first commercialized biosimilar referencing Herceptin in Korea, was approved by the Ministry of Food and Drug Safety in January 2014.

Celltrion also submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA).

At 2:30 p.m. Monday, shares of Celltrion were up 0.05 percent at 210,600 won.

By Shin Chan-ok and Minu Kim

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