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U.S. FDA to review Teva and Celltrion's cancer biosimilar drug
July 31, 2017 / 1:03 PM / 4 months ago

U.S. FDA to review Teva and Celltrion's cancer biosimilar drug

JERUSALEM (Reuters) - Teva Pharmaceutical Industries and South Korea’s Celltrion said on Monday the U.S. Food and Drug Administration has accepted for review a biologics application for a biosimilar drug to treat breast cancer.

FILE PHOTO: A building belonging to Teva Pharmaceutical Industries, the world's biggest generic drugmaker and Israel's largest company, is seen in Jerusalem February 8, 2017. REUTERS/Ronen Zvulun/File Photo

The companies said the FDA has accepted the filing of CT-P6 with regulatory action expected in the first half of 2018. [nBwc10YFha]

CT-P6, already approved by the Korean Ministry of Food and Drug Safety, is a biosimilar -- a copy of a biotech drug -- to Roche Holding’s breast cancer and gastric cancer treatment Herceptin. Earlier this month, an advisory panel to the FDA recommended approval of a Herceptin biosimilar from Mylan and Biocon.

Sales of Herceptin were 3.54 billion Swiss francs ($3.65 billion) in the first half of 2017.

Celltrion and Teva last year entered into an exclusive partnership to commercialize CT-P6 as well as CT-P10 -- a biosimilar to Roche’s blockbuster biotech cancer drug Rituxan -- in the United States and Canada. The FDA is also reviewing a Biologics License Application for CT-P10, with action expected in the first half of 2018.

($1 = 0.9687 Swiss francs)

Reporting by Steven Scheer

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