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.
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)