[Photo by Celltrion Inc.]
South Korea’s leading biosimilar manufacturer Celltrion Inc. won a court decision declaring patents on Roche’s breast cancer drug Herceptin are invalid in Japan, clearing the way to market its copy drug Herzuma in the world’s third largest economy.
The decision is a long-awaited victory for Celltrion, who developed a biosimilar Herzuma to Herceptin, a breast cancer and gastric cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. Herceptin is a blockbuster drug with worldwide sales of about $7 billion, of which about $360 million has been generated from Japan.
Celltrion’s Herzuma was approved for the treatment of gastric cancer in Japan in March, but not for the use of a metastatic breast cancer therapy. With the latest ruling, it can start marketing Herzuma to Japanese hospitals as a breast cancer treatment.
An application for the approval of additional indication will also be filed soon, according to the company.
“Winning approval for the biosimilar after three-year long efforts adds symbolic credential to the Celltrion name. We’re planning to complete all required process by early next year to provide the treatment for people suffering from breast cancer in Japan,” said an official at Celltrion.
On Monday, shares of Celltrion closed 1.48 percent higher at 240,000 won ($213.43) in Seoul trading.
By Kim Hye-soon and Lee Ha-yeon
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